CHAMGAP
MethodologyVerdictsExplanations (KO)Evidence CheckCitation KitMonitoring

BBG-001 × prevention of NEC, sepsis and death in very preterm infants — three primary outcomes evidence sheet

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Comparative efficacyHave the original subclaim verdict and the parent values and context been distinguished?Required
The selected original claim is 'prevention of NEC, sepsis and death', with subclaim grade D and the note 'All were null.'; the parent is D34 with Good safety status.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not fill absent subclaim score, status or axes with parent values. There is no new grade, effect verdict or certification of independence.
Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes
Link additional materials separately to the selected question and the parent context.
2 Partly verified Full text not readStored summary read N02 · Comparative efficacyHave the population and eligibility for prevention in very preterm infants been distinguished from adjunctive treatment?Required
PiPS is a BBG-001 trial to prevent NEC, sepsis and death in very preterm infants; it differs from adding IVIG as adjunctive treatment after sepsis.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Detailed gestational-age and birth-weight criteria, baseline risk, recruitment timing and nutrition or antibiotic conditions are absent from the summary. Do not create new eligibility or product-selection instructions.
Gestational age, birth, recruitment, eligibility, baseline and denominators
Obtain original eligibility, baseline, recruitment, timing and concomitant-exposure materials.
3 Partly verified Full text not readStored summary read N03 · Comparative efficacyWhat are the BBG-001 strain identity, placebo and actual exposure?Required
The study condition was daily administration of the specific Bifidobacterium breve BBG-001 strain or placebo.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not transfer this to other strains, mixtures or probiotics in general. Detailed dose, formulation, manufacturing criteria, start and stop times and actual adherence are absent from the summary. Do not create intake or use instructions.
Original strain, formulation, quality, control, administration duration and actual exposure
Obtain original strain, product, placebo, quality, duration and actual-exposure tables.
4 Partly verified Full text not readStored summary read N04 · Comparative efficacyHave the 1,315 participants and group denominators for the three outcomes been distinguished?Required
The stored summary records 1,315 PiPS participants and the proportions for three events in each group.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly calculate original group sizes, outcome-specific event counts, denominators or missing-data rates. Do not add participants or events as independent evidence when the same infant appears in different events.
Original allocation, group analyses, missing data and event-specific denominators
Obtain original participant flow, group denominators for each outcome, omissions and event mapping.
5 Partly verified Full text not readStored summary read N05 · Comparative efficacyAre sepsis, NEC and death before discharge a single composite event?Required
The evidence list records sepsis, Bell stage 2 or greater NEC and death before discharge as endpoints. The original grade decision records three co-primary outcomes.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn the three outcomes into a newly summed composite event or new structural units. Do not arbitrarily change the existing false indicator for splitting co-primary outcomes.
Three co-primary outcomes, original definitions, individual people or events and time
Obtain the original definition of each endpoint, prespecified hierarchy, overlap, denominators and timing.
6 Partly verified Full text not readStored summary read N06 · Comparative efficacyWhat are the actual sepsis definition, confirmation and observation period?Required
The original evidence list records sepsis as a primary outcome.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not invent details of culture confirmation, clinical diagnosis, timing criteria, repeated events or sepsis categories. The exact observation window and denominators have not been read.
Sepsis definition, testing, confirmation, timing, people or events and denominators
Obtain original sepsis definition, confirmation, timing, denominators and repeated-event tables.
7 Partly verified Full text not readStored summary read N07 · Comparative efficacyAre the sepsis proportions, adjusted RR, 95% CI and original absolute difference preserved?Required
BBG-001 11.2% versus placebo 11.7%, adjusted RR 0.97 (95% CI 0.73~1.29), with an original absolute difference of −0.5%p.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not calculate new event counts, RRs, absolute differences, P values or NNTs from the original proportions. Adjustment variables, missing data and model details have not been read.
Original group order, proportions, adjustment model, effect, CI and denominators
Obtain original event tables, group denominators, adjustment model, tests and CIs.
8 Partly verified Full text not readStored summary read N08 · Comparative efficacyWhat are the definition, classification and verification scope for Bell stage 2 or greater NEC?Required
The evidence list records Bell stage 2 or greater NEC.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not replace this definition with other stages, suspected diagnosis, surgical NEC or nutritional indicators. Detailed adjudication, observation windows and group denominators have not been read.
Original NEC classification, adjudication, timing and denominators
Obtain original Bell definitions, adjudication, results by stage or timing and denominators.
9 Partly verified Full text not readStored summary read N09 · Comparative efficacyHave the original NEC proportions, RR, interval and absolute difference been preserved exactly?Required
The original main-text NEC result is 9.4% versus 10.0%, RR 0.93, interval 0.68~1.27 and original absolute difference −0.6%p. The 95% CI context in the original reader answer is preserved in the full stored review summary.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not arbitrarily fill event counts, new CIs, P values, interval levels or model details absent from the original evidence list.
Original group proportions, effects, intervals, denominators and tests
Obtain original NEC events, denominators, RR, interval, model and tests.
10 Partly verified Full text not readStored summary read N10 · Comparative efficacyHas death before discharge been distinguished from deaths in other periods or from other causes?Required
The evidence list records death before discharge.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not extend the pre-discharge outcome to prevention of death at age 2, throughout life or by other causes. Original cause, duration, denominator and follow-up procedures have not been read in detail.
Death definition, time, cause, denominators and follow-up
Obtain original death definitions, timing, causes, group denominators and follow-up materials.
11 Partly verified Full text not readStored summary read N11 · Comparative efficacyAre the original death proportions, RR, interval and absolute difference preserved?Required
The original main-text death result is 8.3% versus 8.5%, RR 0.93, interval 0.67~1.30 and original absolute difference −0.2%p. The 95% CI context in the original reader answer is preserved in the stored review summary.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not calculate new death counts, RRs, risk differences or P values from the original proportions. Do not mix the death RR with the same RR or CI for NEC.
Original group proportions, original effects, intervals, denominators and tests
Obtain original death tables, denominators, effects, intervals, adjustment and tests.
12 Partly verified Full text not readStored summary read N12 · Comparative efficacyHas the original null result been distinguished from CIs that leave both benefit and harm possible?Required
The stored summary records null results for the three primary outcomes and the limitation that CIs leave both potentially meaningful benefit and harm possible.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly certify a null result as an exact zero effect, equivalence or absence of all harms. There are no new MCIDs, power calculations, sample sizes or hypothetical numerical examples.
Original intervals, precision and clinical importance for each outcome
Obtain original effects, precision, clinical boundaries and denominators for each outcome.
13 Partly verified Full text not readStored summary read N13 · Comparative efficacyHave cross-colonization, within-group colonization and actual event effects been distinguished?Required
The stored summary records BBG-001 colonization in the placebo group and states that prespecified analyses did not explain the null result.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not count colonization as clinical prevention efficacy or an independent trial. Do not add cross-colonization as a new axis defect or certify the original analysis as newly reviewed.
Placebo-group colonization, timing, confirmation, actual exposure and prespecified analyses
Obtain original colonization confirmation, exposure, timing, denominators, prespecified analyses and sensitivity analyses.
14 Partly verified Full text not readStored summary read N14 · Comparative efficacyWhat gaps remain in double blinding, placebo and actual adjudication and analysis procedures?Required
The original evidence list describes PiPS as a multicenter double-blind placebo-controlled RCT.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not invent detailed allocation concealment, blinding checks, event adjudication or analyst procedures. Do not certify nominal blinding as absence of all bias.
Original allocation, concealment, blinding, adjudicators and analysts
Obtain original allocation, blinding, confirmation, analysis and missing-data procedures.
15 Partly verified Full text not readStored summary read N15 · Comparative efficacyWhat gaps remain in the prespecified hierarchy, multiple primary outcomes and registration access?Required
The registration identifier is ISRCTN05511098, and the stored review summary preserves wording about three co-primary outcomes and prespecified colonization analyses.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly read registration, full text or plans. Exact alpha, test P values, multiplicity, ITT or missing-data handling and changes have not been read in detail.
Original registration, protocol, SAP, multiplicity, changes and analysis population
Obtain original registration, plans, hierarchy, multiplicity, analysis populations and changes.
16 Partly verified Full text not readStored summary read N16 · Comparative efficacyHave the single PiPS trial, multiple outcomes and related-verdict links been kept from being added as independent evidence?Required
NEC, sepsis and death before discharge concern the same PiPS report and infant cohort. Verdict 1503 is a cross-citation of an existing verdict on a different strain combination.
R01 R02
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not add the three outcomes or related links as new independent trials or participants. The verdict 1503 target and included trials have not been newly read; final independent counts and participant totals are null.
Relationships among the same trial, reports, cohort, outcomes and cross-citations
Link additional reports by original identifiers, participants, outcomes and strain relationships.
17 Partly verified Full text not readStored summary read N17 · Comparative efficacyHave the original cross-citation of the verdict 1503 strain combination and new direct evidence been separated?Required
The stored summary cross-cites verdict 1503, where a Bifidobacterium plus Lactobacillus combination had NEC and total-mortality benefit, B77, in the same preterm prevention indication.
R01 R02
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. That verdict and its original trials have not been read or reassessed in this preparation. Do not transfer effects of another combination to BBG-001 or create a direct product-superiority comparison.
Existing related-verdict record, strains, population, trials and denominators
Link relevant original materials provided by the user by strain, comparison and cohort.
18 Partly verified Full text not readStored summary read N18 · Comparative efficacyHave NIHR cash funding, Yakult in-kind provision and study roles each been preserved?Required
Preserve the NIHR HTA research funding and Yakult Honsha's free manufacture and transport to the UK of probiotic and placebo products. The stored summary records no company involvement in design, conduct or analysis.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly certify absence of in-kind provision or complete independence solely from public support. Employee authors and other writing roles have not been separately read; preserve original I1.
Funding, product or placebo manufacture, transport, affiliations, analysis and study roles
Obtain original disclosures on funding, in-kind provision, affiliations, design, conduct, analysis and writing.
19 Partly verified Full text not readStored summary read N19 · Supplementary harm evidenceHave nonreporting of a probiotic-bacteremia signal and the original event intervals been separated?Required
The original safety description states that no major safety signal, including probiotic bacteremia, was reported and that the three primary events did not increase.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn nonreporting into zero bacteremia events, absence of harm or certification of long-term safety. Preserve as historical both the possibility of harm within the original effect CIs and the original Good safety verdict.
Harm definition, collection, people or events, exposure, denominators and relatedness
Obtain original harm collection, group events or people, denominators, relatedness, exposure and CIs.
20 Unverified Full text not readStored summary read N20 · Supplementary harm evidenceWhat gaps remain in exposure duration, missing data, safety-analysis populations and rare harms?Required
The stored summary preserves daily study-product administration and descriptions of primary events and safety signals.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly calculate specific administration durations, safety populations, repeated events, rare-harm rates, discontinuation or long-term follow-up.
Actual exposure, harm denominators, observation windows, relatedness and discontinuation
Obtain original exposure, safety-analysis population, discontinuation, missing-data, follow-up and relatedness materials.
21 Unverified Full text not readStored summary read N21 · Supplementary harm evidenceDo gaps remain when applying effects or harms to other populations, strains, combinations or durations?Required
The stored summary distinguishes prevention with the specific BBG-001 strain in very preterm infants from results for other combination products.
R01 R02
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not treat all probiotics as ineffective or safe, or equate their effects with those of other strains. There are no neonatal product-selection, use or suitability instructions.
Direct comparisons and independent relationships by population, strain, formulation and duration
Obtain direct effect and harm materials by population, strain, combination and duration.
22 Partly verified Full text not readStored summary read N22 · Comparative efficacyAre the stored summary, original URLs, registration identifier and access to linked targets distinguished?Required
The full stored summary of the designated parent verdict was read for preparation, and the original citation-list URLs and registration identifier are preserved.
R01 R02
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. External abstracts, full texts, registration, protocols, SAPs and targets of related-verdict links have not been read. Do not create new URLs or DOIs from identifiers or perform separate link tests.
Reports or cross-citations, URLs, identifiers and access by material
Link user-provided original materials to each material type and access status.
23 Partly verified Full text not readStored summary read N23 · Comparative efficacyHave the Korean and English manuscripts, original axes, dates, corrections, empty values, candidate history and preparation status been preserved?Supplementary
Preserve 2026-08-26, empty correction and deliberation values, subclaim grade D and its note, and the actual parent grade, score, safety, assessment axes and Korean and English manuscripts.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Original verification, funding independence, design-defect and safety descriptions are historical, not certification of the present review. Do not fill absent subclaim fields; original review-pending and preparation-eligible indicators are candidate history.
Distinguish the selected verdict record, complete parent, original languages and history from current preparation
Preserve user materials and decisions in full, then link them as separate events.
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23 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-08-26
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
PiPS prevention in very preterm infants; detailed eligibility and baseline information not read
Ingredient, formulation and route
Historical exposure in a prevention trial of the specific BBG-001 strain; no recommendation for use
Dose
Only the original daily administration condition is preserved; no dosing, duration or procedural guidance is created
Comparator
Placebo; detailed actual concomitant exposures not read
Measured outcome
Distinguish sepsis, Bell stage 2 or greater NEC and death before discharge by their individual definitions and original results within one existing question
Duration
Apart from death before discharge, exact observation windows by event and actual administration duration have not been read in detail
Questions outside this scope
Adding individual or composite events as new units, independent trials or participants; Certifying a null result, confidence interval or nonreporting as an exact zero effect or absence of all harms; Combining BBG-001 prevention with adjunctive IVIG treatment after infection; Transferring effects to other strains, products, durations or populations; Recommendations on neonatal product selection, use, suitability, administration or treatment

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Costeloe K, et al. Lancet. 2016;387:649-660. PMID: 26628328.

PubMed

Material type
Original trial paper report
Materials actually read
Summary read; external or linked material unread
Findings recorded in the stored summary
Sepsis: BBG-001 11.2% versus placebo 11.7%, absolute difference -0.5%p, adjusted RR 0.97 (95% CI 0.73~1.29); NEC 9.4% versus 10.0%; death 8.3% versus 8.5%
Record level
Existing review summary; no comparison with the external original report
Study overlap and independent replication
Three co-primary outcomes in the same PiPS trial and infant cohort; a cross-citation of existing verdict 1503 on a different strain combination, whose linked target and included trials have not been read and which does not certify independent replication of BBG-001; family IDs link relationships and do not certify independent counts; do not newly add events, composite components, sites, cross-citations or the same participants as independent evidence
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
local_summaryOriginal URL preservedSummary readSummary readPreserved parent verdict summary; report-specific links to the same stored summary copy
abstractOriginal URL preservedNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
fulltextNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
registrationNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
protocol_sapNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete

R02 · Verdict 1503: Bifidobacterium plus Lactobacillus combination probiotics × prevention of NEC and total mortality in preterm infants (B 77)

Official source

Material type
Cross-citation to an existing verdict; original trial report/bibliography not acquired
Materials actually read
Summary read; external or linked material unread
Findings recorded in the stored summary
Outcomes differ by strain and combination within the same indication.
Record level
Only the original cross-citation summary is preserved; no new clinical evidence on other strains has been read
Study overlap and independent replication
Three co-primary outcomes in the same PiPS trial and infant cohort; a cross-citation of existing verdict 1503 on a different strain combination, whose linked target and included trials have not been read and which does not certify independent replication of BBG-001; family IDs link relationships and do not certify independent counts; do not newly add events, composite components, sites, cross-citations or the same participants as independent evidence
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
local_summaryOriginal URL preservedSummary readSummary readPreserved parent verdict summary; report-specific links to the same stored summary copy
source_linkOriginal URL preservedNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
fulltextNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
registrationNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
protocol_sapNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete

Report counts versus independent study counts

Three co-primary outcomes in the same PiPS trial and infant cohort; a cross-citation of existing verdict 1503 on a different strain combination, whose linked target and included trials have not been read and which does not certify independent replication of BBG-001; family IDs link relationships and do not certify independent counts; do not newly add events, composite components, sites, cross-citations or the same participants as independent evidence

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Have the original subclaim verdict and the parent values and context been distinguished?
Required materials and conditions
Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes
Conditions for verification
Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N02 · Have the population and eligibility for prevention in very preterm infants been distinguished from adjunctive treatment?
Required materials and conditions
Gestational age, birth, recruitment, eligibility, baseline and denominators
Conditions for verification
Gestational age, birth, recruitment, eligibility, baseline and denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N03 · What are the BBG-001 strain identity, placebo and actual exposure?
Required materials and conditions
Original strain, formulation, quality, control, administration duration and actual exposure
Conditions for verification
Original strain, formulation, quality, control, administration duration and actual exposure
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N04 · Have the 1,315 participants and group denominators for the three outcomes been distinguished?
Required materials and conditions
Original allocation, group analyses, missing data and event-specific denominators
Conditions for verification
Original allocation, group analyses, missing data and event-specific denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N05 · Are sepsis, NEC and death before discharge a single composite event?
Required materials and conditions
Three co-primary outcomes, original definitions, individual people or events and time
Conditions for verification
Three co-primary outcomes, original definitions, individual people or events and time
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N06 · What are the actual sepsis definition, confirmation and observation period?
Required materials and conditions
Sepsis definition, testing, confirmation, timing, people or events and denominators
Conditions for verification
Sepsis definition, testing, confirmation, timing, people or events and denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N07 · Are the sepsis proportions, adjusted RR, 95% CI and original absolute difference preserved?
Required materials and conditions
Original group order, proportions, adjustment model, effect, CI and denominators
Conditions for verification
Original group order, proportions, adjustment model, effect, CI and denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N08 · What are the definition, classification and verification scope for Bell stage 2 or greater NEC?
Required materials and conditions
Original NEC classification, adjudication, timing and denominators
Conditions for verification
Original NEC classification, adjudication, timing and denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N09 · Have the original NEC proportions, RR, interval and absolute difference been preserved exactly?
Required materials and conditions
Original group proportions, effects, intervals, denominators and tests
Conditions for verification
Original group proportions, effects, intervals, denominators and tests
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N10 · Has death before discharge been distinguished from deaths in other periods or from other causes?
Required materials and conditions
Death definition, time, cause, denominators and follow-up
Conditions for verification
Death definition, time, cause, denominators and follow-up
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N11 · Are the original death proportions, RR, interval and absolute difference preserved?
Required materials and conditions
Original group proportions, original effects, intervals, denominators and tests
Conditions for verification
Original group proportions, original effects, intervals, denominators and tests
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N12 · Has the original null result been distinguished from CIs that leave both benefit and harm possible?
Required materials and conditions
Original intervals, precision and clinical importance for each outcome
Conditions for verification
Original intervals, precision and clinical importance for each outcome
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N13 · Have cross-colonization, within-group colonization and actual event effects been distinguished?
Required materials and conditions
Placebo-group colonization, timing, confirmation, actual exposure and prespecified analyses
Conditions for verification
Placebo-group colonization, timing, confirmation, actual exposure and prespecified analyses
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N14 · What gaps remain in double blinding, placebo and actual adjudication and analysis procedures?
Required materials and conditions
Original allocation, concealment, blinding, adjudicators and analysts
Conditions for verification
Original allocation, concealment, blinding, adjudicators and analysts
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N15 · What gaps remain in the prespecified hierarchy, multiple primary outcomes and registration access?
Required materials and conditions
Original registration, protocol, SAP, multiplicity, changes and analysis population
Conditions for verification
Original registration, protocol, SAP, multiplicity, changes and analysis population
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N16 · Have the single PiPS trial, multiple outcomes and related-verdict links been kept from being added as independent evidence?
Required materials and conditions
Relationships among the same trial, reports, cohort, outcomes and cross-citations
Conditions for verification
Relationships among the same trial, reports, cohort, outcomes and cross-citations
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N17 · Have the original cross-citation of the verdict 1503 strain combination and new direct evidence been separated?
Required materials and conditions
Existing related-verdict record, strains, population, trials and denominators
Conditions for verification
Existing related-verdict record, strains, population, trials and denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N18 · Have NIHR cash funding, Yakult in-kind provision and study roles each been preserved?
Required materials and conditions
Funding, product or placebo manufacture, transport, affiliations, analysis and study roles
Conditions for verification
Funding, product or placebo manufacture, transport, affiliations, analysis and study roles
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N19 · Have nonreporting of a probiotic-bacteremia signal and the original event intervals been separated?
Required materials and conditions
Harm definition, collection, people or events, exposure, denominators and relatedness
Conditions for verification
Harm definition, collection, people or events, exposure, denominators and relatedness
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N20 · What gaps remain in exposure duration, missing data, safety-analysis populations and rare harms?
Required materials and conditions
Actual exposure, harm denominators, observation windows, relatedness and discontinuation
Conditions for verification
Actual exposure, harm denominators, observation windows, relatedness and discontinuation
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N21 · Do gaps remain when applying effects or harms to other populations, strains, combinations or durations?
Required materials and conditions
Direct comparisons and independent relationships by population, strain, formulation and duration
Conditions for verification
Direct comparisons and independent relationships by population, strain, formulation and duration
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N22 · Are the stored summary, original URLs, registration identifier and access to linked targets distinguished?
Required materials and conditions
Reports or cross-citations, URLs, identifiers and access by material
Conditions for verification
Reports or cross-citations, URLs, identifiers and access by material
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
N23 · Have the Korean and English manuscripts, original axes, dates, corrections, empty values, candidate history and preparation status been preserved?
Required materials and conditions
Distinguish the selected verdict record, complete parent, original languages and history from current preparation
Conditions for verification
Distinguish the selected verdict record, complete parent, original languages and history from current preparation
Requirement and applicability
Supplementary
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Prevention of NEC, sepsis and death
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing
What the statuses mean
Partly verified
Some information exists in the preserved review summary, with detailed original materials still unverified; no certification of a passed review or clinical efficacy
Unverified
Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete
Review of existing content incomplete
Met
Use only within the relevant condition's scope after user review; no automatic display in this preparation
Not reported
Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible
Not applied during this preparation because actual access was not tested
Not applicable
Use with a reason for non-applicability based on an explicit question boundary
Conflicting data
Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions
Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-10 · Public page/material version 1.0

Reader pages and materials were prepared from the existing 23 items. No new clinical search, change in verification status or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Have the original subclaim verdict and the parent values and context been distinguished?

Current findings
The selected original claim is 'prevention of NEC, sepsis and death', with subclaim grade D and the note 'All were null.'; the parent is D34 with Good safety status.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not fill absent subclaim score, status or axes with parent values. There is no new grade, effect verdict or certification of independence.
Reason for missing information
Do not fill absent subclaim score, status or axes with parent values. There is no new grade, effect verdict or certification of independence.
Required materials and conditions
Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes
Materials to obtain first
Do not fill absent subclaim score, status or axes with parent values. There is no new grade, effect verdict or certification of independence.
Further research
Link additional materials separately to the selected question and the parent context.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N02 · Have the population and eligibility for prevention in very preterm infants been distinguished from adjunctive treatment?

Current findings
PiPS is a BBG-001 trial to prevent NEC, sepsis and death in very preterm infants; it differs from adding IVIG as adjunctive treatment after sepsis.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Detailed gestational-age and birth-weight criteria, baseline risk, recruitment timing and nutrition or antibiotic conditions are absent from the summary. Do not create new eligibility or product-selection instructions.
Reason for missing information
Detailed gestational-age and birth-weight criteria, baseline risk, recruitment timing and nutrition or antibiotic conditions are absent from the summary. Do not create new eligibility or product-selection instructions.
Required materials and conditions
Gestational age, birth, recruitment, eligibility, baseline and denominators
Materials to obtain first
Detailed gestational-age and birth-weight criteria, baseline risk, recruitment timing and nutrition or antibiotic conditions are absent from the summary. Do not create new eligibility or product-selection instructions.
Further research
Obtain original eligibility, baseline, recruitment, timing and concomitant-exposure materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Gestational age, birth, recruitment, eligibility, baseline and denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N03 · What are the BBG-001 strain identity, placebo and actual exposure?

Current findings
The study condition was daily administration of the specific Bifidobacterium breve BBG-001 strain or placebo.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not transfer this to other strains, mixtures or probiotics in general. Detailed dose, formulation, manufacturing criteria, start and stop times and actual adherence are absent from the summary. Do not create intake or use instructions.
Reason for missing information
Do not transfer this to other strains, mixtures or probiotics in general. Detailed dose, formulation, manufacturing criteria, start and stop times and actual adherence are absent from the summary. Do not create intake or use instructions.
Required materials and conditions
Original strain, formulation, quality, control, administration duration and actual exposure
Materials to obtain first
Do not transfer this to other strains, mixtures or probiotics in general. Detailed dose, formulation, manufacturing criteria, start and stop times and actual adherence are absent from the summary. Do not create intake or use instructions.
Further research
Obtain original strain, product, placebo, quality, duration and actual-exposure tables.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original strain, formulation, quality, control, administration duration and actual exposure
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N04 · Have the 1,315 participants and group denominators for the three outcomes been distinguished?

Current findings
The stored summary records 1,315 PiPS participants and the proportions for three events in each group.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly calculate original group sizes, outcome-specific event counts, denominators or missing-data rates. Do not add participants or events as independent evidence when the same infant appears in different events.
Reason for missing information
Do not newly calculate original group sizes, outcome-specific event counts, denominators or missing-data rates. Do not add participants or events as independent evidence when the same infant appears in different events.
Required materials and conditions
Original allocation, group analyses, missing data and event-specific denominators
Materials to obtain first
Do not newly calculate original group sizes, outcome-specific event counts, denominators or missing-data rates. Do not add participants or events as independent evidence when the same infant appears in different events.
Further research
Obtain original participant flow, group denominators for each outcome, omissions and event mapping.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original allocation, group analyses, missing data and event-specific denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N05 · Are sepsis, NEC and death before discharge a single composite event?

Current findings
The evidence list records sepsis, Bell stage 2 or greater NEC and death before discharge as endpoints. The original grade decision records three co-primary outcomes.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn the three outcomes into a newly summed composite event or new structural units. Do not arbitrarily change the existing false indicator for splitting co-primary outcomes.
Reason for missing information
Do not turn the three outcomes into a newly summed composite event or new structural units. Do not arbitrarily change the existing false indicator for splitting co-primary outcomes.
Required materials and conditions
Three co-primary outcomes, original definitions, individual people or events and time
Materials to obtain first
Do not turn the three outcomes into a newly summed composite event or new structural units. Do not arbitrarily change the existing false indicator for splitting co-primary outcomes.
Further research
Obtain the original definition of each endpoint, prespecified hierarchy, overlap, denominators and timing.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Three co-primary outcomes, original definitions, individual people or events and time
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N06 · What are the actual sepsis definition, confirmation and observation period?

Current findings
The original evidence list records sepsis as a primary outcome.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not invent details of culture confirmation, clinical diagnosis, timing criteria, repeated events or sepsis categories. The exact observation window and denominators have not been read.
Reason for missing information
Do not invent details of culture confirmation, clinical diagnosis, timing criteria, repeated events or sepsis categories. The exact observation window and denominators have not been read.
Required materials and conditions
Sepsis definition, testing, confirmation, timing, people or events and denominators
Materials to obtain first
Do not invent details of culture confirmation, clinical diagnosis, timing criteria, repeated events or sepsis categories. The exact observation window and denominators have not been read.
Further research
Obtain original sepsis definition, confirmation, timing, denominators and repeated-event tables.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Sepsis definition, testing, confirmation, timing, people or events and denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N07 · Are the sepsis proportions, adjusted RR, 95% CI and original absolute difference preserved?

Current findings
BBG-001 11.2% versus placebo 11.7%, adjusted RR 0.97 (95% CI 0.73~1.29), with an original absolute difference of −0.5%p.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not calculate new event counts, RRs, absolute differences, P values or NNTs from the original proportions. Adjustment variables, missing data and model details have not been read.
Reason for missing information
Do not calculate new event counts, RRs, absolute differences, P values or NNTs from the original proportions. Adjustment variables, missing data and model details have not been read.
Required materials and conditions
Original group order, proportions, adjustment model, effect, CI and denominators
Materials to obtain first
Do not calculate new event counts, RRs, absolute differences, P values or NNTs from the original proportions. Adjustment variables, missing data and model details have not been read.
Further research
Obtain original event tables, group denominators, adjustment model, tests and CIs.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original group order, proportions, adjustment model, effect, CI and denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N08 · What are the definition, classification and verification scope for Bell stage 2 or greater NEC?

Current findings
The evidence list records Bell stage 2 or greater NEC.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not replace this definition with other stages, suspected diagnosis, surgical NEC or nutritional indicators. Detailed adjudication, observation windows and group denominators have not been read.
Reason for missing information
Do not replace this definition with other stages, suspected diagnosis, surgical NEC or nutritional indicators. Detailed adjudication, observation windows and group denominators have not been read.
Required materials and conditions
Original NEC classification, adjudication, timing and denominators
Materials to obtain first
Do not replace this definition with other stages, suspected diagnosis, surgical NEC or nutritional indicators. Detailed adjudication, observation windows and group denominators have not been read.
Further research
Obtain original Bell definitions, adjudication, results by stage or timing and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original NEC classification, adjudication, timing and denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N09 · Have the original NEC proportions, RR, interval and absolute difference been preserved exactly?

Current findings
The original main-text NEC result is 9.4% versus 10.0%, RR 0.93, interval 0.68~1.27 and original absolute difference −0.6%p. The 95% CI context in the original reader answer is preserved in the full stored review summary.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not arbitrarily fill event counts, new CIs, P values, interval levels or model details absent from the original evidence list.
Reason for missing information
Do not arbitrarily fill event counts, new CIs, P values, interval levels or model details absent from the original evidence list.
Required materials and conditions
Original group proportions, effects, intervals, denominators and tests
Materials to obtain first
Do not arbitrarily fill event counts, new CIs, P values, interval levels or model details absent from the original evidence list.
Further research
Obtain original NEC events, denominators, RR, interval, model and tests.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original group proportions, effects, intervals, denominators and tests
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N10 · Has death before discharge been distinguished from deaths in other periods or from other causes?

Current findings
The evidence list records death before discharge.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not extend the pre-discharge outcome to prevention of death at age 2, throughout life or by other causes. Original cause, duration, denominator and follow-up procedures have not been read in detail.
Reason for missing information
Do not extend the pre-discharge outcome to prevention of death at age 2, throughout life or by other causes. Original cause, duration, denominator and follow-up procedures have not been read in detail.
Required materials and conditions
Death definition, time, cause, denominators and follow-up
Materials to obtain first
Do not extend the pre-discharge outcome to prevention of death at age 2, throughout life or by other causes. Original cause, duration, denominator and follow-up procedures have not been read in detail.
Further research
Obtain original death definitions, timing, causes, group denominators and follow-up materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Death definition, time, cause, denominators and follow-up
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N11 · Are the original death proportions, RR, interval and absolute difference preserved?

Current findings
The original main-text death result is 8.3% versus 8.5%, RR 0.93, interval 0.67~1.30 and original absolute difference −0.2%p. The 95% CI context in the original reader answer is preserved in the stored review summary.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not calculate new death counts, RRs, risk differences or P values from the original proportions. Do not mix the death RR with the same RR or CI for NEC.
Reason for missing information
Do not calculate new death counts, RRs, risk differences or P values from the original proportions. Do not mix the death RR with the same RR or CI for NEC.
Required materials and conditions
Original group proportions, original effects, intervals, denominators and tests
Materials to obtain first
Do not calculate new death counts, RRs, risk differences or P values from the original proportions. Do not mix the death RR with the same RR or CI for NEC.
Further research
Obtain original death tables, denominators, effects, intervals, adjustment and tests.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original group proportions, original effects, intervals, denominators and tests
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N12 · Has the original null result been distinguished from CIs that leave both benefit and harm possible?

Current findings
The stored summary records null results for the three primary outcomes and the limitation that CIs leave both potentially meaningful benefit and harm possible.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly certify a null result as an exact zero effect, equivalence or absence of all harms. There are no new MCIDs, power calculations, sample sizes or hypothetical numerical examples.
Reason for missing information
Do not newly certify a null result as an exact zero effect, equivalence or absence of all harms. There are no new MCIDs, power calculations, sample sizes or hypothetical numerical examples.
Required materials and conditions
Original intervals, precision and clinical importance for each outcome
Materials to obtain first
Do not newly certify a null result as an exact zero effect, equivalence or absence of all harms. There are no new MCIDs, power calculations, sample sizes or hypothetical numerical examples.
Further research
Obtain original effects, precision, clinical boundaries and denominators for each outcome.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original intervals, precision and clinical importance for each outcome
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N13 · Have cross-colonization, within-group colonization and actual event effects been distinguished?

Current findings
The stored summary records BBG-001 colonization in the placebo group and states that prespecified analyses did not explain the null result.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not count colonization as clinical prevention efficacy or an independent trial. Do not add cross-colonization as a new axis defect or certify the original analysis as newly reviewed.
Reason for missing information
Do not count colonization as clinical prevention efficacy or an independent trial. Do not add cross-colonization as a new axis defect or certify the original analysis as newly reviewed.
Required materials and conditions
Placebo-group colonization, timing, confirmation, actual exposure and prespecified analyses
Materials to obtain first
Do not count colonization as clinical prevention efficacy or an independent trial. Do not add cross-colonization as a new axis defect or certify the original analysis as newly reviewed.
Further research
Obtain original colonization confirmation, exposure, timing, denominators, prespecified analyses and sensitivity analyses.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Placebo-group colonization, timing, confirmation, actual exposure and prespecified analyses
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N14 · What gaps remain in double blinding, placebo and actual adjudication and analysis procedures?

Current findings
The original evidence list describes PiPS as a multicenter double-blind placebo-controlled RCT.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not invent detailed allocation concealment, blinding checks, event adjudication or analyst procedures. Do not certify nominal blinding as absence of all bias.
Reason for missing information
Do not invent detailed allocation concealment, blinding checks, event adjudication or analyst procedures. Do not certify nominal blinding as absence of all bias.
Required materials and conditions
Original allocation, concealment, blinding, adjudicators and analysts
Materials to obtain first
Do not invent detailed allocation concealment, blinding checks, event adjudication or analyst procedures. Do not certify nominal blinding as absence of all bias.
Further research
Obtain original allocation, blinding, confirmation, analysis and missing-data procedures.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original allocation, concealment, blinding, adjudicators and analysts
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N15 · What gaps remain in the prespecified hierarchy, multiple primary outcomes and registration access?

Current findings
The registration identifier is ISRCTN05511098, and the stored review summary preserves wording about three co-primary outcomes and prespecified colonization analyses.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly read registration, full text or plans. Exact alpha, test P values, multiplicity, ITT or missing-data handling and changes have not been read in detail.
Reason for missing information
Do not newly read registration, full text or plans. Exact alpha, test P values, multiplicity, ITT or missing-data handling and changes have not been read in detail.
Required materials and conditions
Original registration, protocol, SAP, multiplicity, changes and analysis population
Materials to obtain first
Do not newly read registration, full text or plans. Exact alpha, test P values, multiplicity, ITT or missing-data handling and changes have not been read in detail.
Further research
Obtain original registration, plans, hierarchy, multiplicity, analysis populations and changes.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original registration, protocol, SAP, multiplicity, changes and analysis population
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N16 · Have the single PiPS trial, multiple outcomes and related-verdict links been kept from being added as independent evidence?

Current findings
NEC, sepsis and death before discharge concern the same PiPS report and infant cohort. Verdict 1503 is a cross-citation of an existing verdict on a different strain combination.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not add the three outcomes or related links as new independent trials or participants. The verdict 1503 target and included trials have not been newly read; final independent counts and participant totals are null.
Reason for missing information
Do not add the three outcomes or related links as new independent trials or participants. The verdict 1503 target and included trials have not been newly read; final independent counts and participant totals are null.
Required materials and conditions
Relationships among the same trial, reports, cohort, outcomes and cross-citations
Materials to obtain first
Do not add the three outcomes or related links as new independent trials or participants. The verdict 1503 target and included trials have not been newly read; final independent counts and participant totals are null.
Further research
Link additional reports by original identifiers, participants, outcomes and strain relationships.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Relationships among the same trial, reports, cohort, outcomes and cross-citations
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01 R02

N17 · Have the original cross-citation of the verdict 1503 strain combination and new direct evidence been separated?

Current findings
The stored summary cross-cites verdict 1503, where a Bifidobacterium plus Lactobacillus combination had NEC and total-mortality benefit, B77, in the same preterm prevention indication.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. That verdict and its original trials have not been read or reassessed in this preparation. Do not transfer effects of another combination to BBG-001 or create a direct product-superiority comparison.
Reason for missing information
That verdict and its original trials have not been read or reassessed in this preparation. Do not transfer effects of another combination to BBG-001 or create a direct product-superiority comparison.
Required materials and conditions
Existing related-verdict record, strains, population, trials and denominators
Materials to obtain first
That verdict and its original trials have not been read or reassessed in this preparation. Do not transfer effects of another combination to BBG-001 or create a direct product-superiority comparison.
Further research
Link relevant original materials provided by the user by strain, comparison and cohort.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Existing related-verdict record, strains, population, trials and denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01 R02

N18 · Have NIHR cash funding, Yakult in-kind provision and study roles each been preserved?

Current findings
Preserve the NIHR HTA research funding and Yakult Honsha's free manufacture and transport to the UK of probiotic and placebo products. The stored summary records no company involvement in design, conduct or analysis.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly certify absence of in-kind provision or complete independence solely from public support. Employee authors and other writing roles have not been separately read; preserve original I1.
Reason for missing information
Do not newly certify absence of in-kind provision or complete independence solely from public support. Employee authors and other writing roles have not been separately read; preserve original I1.
Required materials and conditions
Funding, product or placebo manufacture, transport, affiliations, analysis and study roles
Materials to obtain first
Do not newly certify absence of in-kind provision or complete independence solely from public support. Employee authors and other writing roles have not been separately read; preserve original I1.
Further research
Obtain original disclosures on funding, in-kind provision, affiliations, design, conduct, analysis and writing.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Funding, product or placebo manufacture, transport, affiliations, analysis and study roles
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N19 · Have nonreporting of a probiotic-bacteremia signal and the original event intervals been separated?

Current findings
The original safety description states that no major safety signal, including probiotic bacteremia, was reported and that the three primary events did not increase.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn nonreporting into zero bacteremia events, absence of harm or certification of long-term safety. Preserve as historical both the possibility of harm within the original effect CIs and the original Good safety verdict.
Reason for missing information
Do not turn nonreporting into zero bacteremia events, absence of harm or certification of long-term safety. Preserve as historical both the possibility of harm within the original effect CIs and the original Good safety verdict.
Required materials and conditions
Harm definition, collection, people or events, exposure, denominators and relatedness
Materials to obtain first
Do not turn nonreporting into zero bacteremia events, absence of harm or certification of long-term safety. Preserve as historical both the possibility of harm within the original effect CIs and the original Good safety verdict.
Further research
Obtain original harm collection, group events or people, denominators, relatedness, exposure and CIs.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Harm definition, collection, people or events, exposure, denominators and relatedness
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N20 · What gaps remain in exposure duration, missing data, safety-analysis populations and rare harms?

Current findings
The stored summary preserves daily study-product administration and descriptions of primary events and safety signals.
Verification status
Unverified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly calculate specific administration durations, safety populations, repeated events, rare-harm rates, discontinuation or long-term follow-up.
Reason for missing information
Do not newly calculate specific administration durations, safety populations, repeated events, rare-harm rates, discontinuation or long-term follow-up.
Required materials and conditions
Actual exposure, harm denominators, observation windows, relatedness and discontinuation
Materials to obtain first
Do not newly calculate specific administration durations, safety populations, repeated events, rare-harm rates, discontinuation or long-term follow-up.
Further research
Obtain original exposure, safety-analysis population, discontinuation, missing-data, follow-up and relatedness materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Actual exposure, harm denominators, observation windows, relatedness and discontinuation
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01

N21 · Do gaps remain when applying effects or harms to other populations, strains, combinations or durations?

Current findings
The stored summary distinguishes prevention with the specific BBG-001 strain in very preterm infants from results for other combination products.
Verification status
Unverified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not treat all probiotics as ineffective or safe, or equate their effects with those of other strains. There are no neonatal product-selection, use or suitability instructions.
Reason for missing information
Do not treat all probiotics as ineffective or safe, or equate their effects with those of other strains. There are no neonatal product-selection, use or suitability instructions.
Required materials and conditions
Direct comparisons and independent relationships by population, strain, formulation and duration
Materials to obtain first
Do not treat all probiotics as ineffective or safe, or equate their effects with those of other strains. There are no neonatal product-selection, use or suitability instructions.
Further research
Obtain direct effect and harm materials by population, strain, combination and duration.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Direct comparisons and independent relationships by population, strain, formulation and duration
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01 R02

N22 · Are the stored summary, original URLs, registration identifier and access to linked targets distinguished?

Current findings
The full stored summary of the designated parent verdict was read for preparation, and the original citation-list URLs and registration identifier are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. External abstracts, full texts, registration, protocols, SAPs and targets of related-verdict links have not been read. Do not create new URLs or DOIs from identifiers or perform separate link tests.
Reason for missing information
External abstracts, full texts, registration, protocols, SAPs and targets of related-verdict links have not been read. Do not create new URLs or DOIs from identifiers or perform separate link tests.
Required materials and conditions
Reports or cross-citations, URLs, identifiers and access by material
Materials to obtain first
External abstracts, full texts, registration, protocols, SAPs and targets of related-verdict links have not been read. Do not create new URLs or DOIs from identifiers or perform separate link tests.
Further research
Link user-provided original materials to each material type and access status.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Reports or cross-citations, URLs, identifiers and access by material
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01 R02

N23 · Have the Korean and English manuscripts, original axes, dates, corrections, empty values, candidate history and preparation status been preserved?

Current findings
Preserve 2026-08-26, empty correction and deliberation values, subclaim grade D and its note, and the actual parent grade, score, safety, assessment axes and Korean and English manuscripts.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Original verification, funding independence, design-defect and safety descriptions are historical, not certification of the present review. Do not fill absent subclaim fields; original review-pending and preparation-eligible indicators are candidate history.
Reason for missing information
Original verification, funding independence, design-defect and safety descriptions are historical, not certification of the present review. Do not fill absent subclaim fields; original review-pending and preparation-eligible indicators are candidate history.
Required materials and conditions
Distinguish the selected verdict record, complete parent, original languages and history from current preparation
Materials to obtain first
Original verification, funding independence, design-defect and safety descriptions are historical, not certification of the present review. Do not fill absent subclaim fields; original review-pending and preparation-eligible indicators are candidate history.
Further research
Preserve user materials and decisions in full, then link them as separate events.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Distinguish the selected verdict record, complete parent, original languages and history from current preparation
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Prevention of NEC, sepsis and death

Related sources R01