CHAMGAP
MethodologyVerdictsExplanations (KO)Evidence CheckCitation KitMonitoring

Adjunctive intravenous immunoglobulin × death or major disability at age 2 in neonates — composite outcome 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 verdict concerns 'reduction in death or major disability', with subclaim grade D and the note 'RR was 1.00.'; the parent is D34 with Caution.
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 efficacyWho was the original population receiving antibiotics for suspected or confirmed sepsis?Required
INIS asks about adjunctive IVIG in neonates already receiving antibiotics for suspected or confirmed sepsis.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not combine this with trials of prevention before infection in extremely preterm infants. Original gestational age, birth weight, diagnostic or testing criteria and detailed eligibility have not been read.
Original sepsis definition, eligibility, baseline, entry timing and denominators
Obtain original population, diagnosis, eligibility, baseline and entry-timing materials.
3 Partly verified Full text not readStored summary read N03 · Comparative efficacyWhat was the actual comparison of added IVIG versus placebo with antibiotics common to both groups?Required
All infants received antibiotics, and the international double-blind RCT compared added IVIG with placebo.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn this into IVIG alone, replacement of antibiotics or selection of a particular product. Placebo ingredients, the IVIG product and details of common antibiotics or treatment have not been read.
Original IVIG identity, placebo, common antibiotics, concomitant treatment and actual exposure
Obtain original product, placebo, common treatment, concomitant treatment and changes.
4 Partly verified Full text not readStored summary read N04 · Comparative efficacyHave the original administration exposure, actual completion and safety denominators been separated?Required
The historical regimen in the review summary is IVIG 500mg/kg given twice, 48 hours apart.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not create individual administration, dosing, infusion or suitability guidance. Detailed actual completion, placebo exposure, discontinuation and safety denominators have not been read.
Original study plan, actual administration, omissions, exposure and denominators
Obtain original tables of planned and actual administration, omissions, discontinuation and exposure.
5 Partly verified Full text not readStored summary read N05 · Comparative efficacyHave the 113 hospitals, 3,493 participants and analysis by assigned group been preserved?Required
The stored review summary states that 3,493 participants at 113 hospitals were randomized and analyzed by assigned group. Composite outcome denominators are 1,759/1,734.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not count multiple sites or denominators as independent trials. Do not invent group follow-up, omissions, imputation or exceptions, or certify completed disability assessment for everyone.
Original allocation, group denominators, analysis population, sites and missing data
Obtain original participant flow, analysis population, group denominators, follow-up and missing-data handling.
6 Partly verified Full text not readStored summary read N06 · Comparative efficacyWhat is the composite definition of death or major disability at age 2?Required
The original endpoint is death or major disability at age 2. Preserve the composite result within one selected question.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not split components into new units or simply add them together. Details are absent on whether age 2 is corrected age, disability scales or criteria, assessors, methods and handling of overlap.
Composite events, components, severity criteria, instruments, assessment timing and denominators
Obtain the original composite definition, severity criteria, instruments, assessed population, timing and denominators.
7 Partly verified Full text not readStored summary read N07 · Comparative efficacyHave 686/1759, 677/1734 and the original 39.0% been preserved?Required
Death or major disability at age 2 was IVIG 686/1759 (39.0%) versus placebo 677/1734 (39.0%).
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn equal rounded proportions into equality of every component or exact risks. Do not calculate event or participant totals, new proportions or group differences.
Original group order, composite events, original denominators, people versus events and proportions
Obtain original composite event tables, denominators, components, overlap and missing data.
8 Partly verified Full text not readStored summary read N08 · Comparative efficacyHave RR 1.00, 95% CI 0.92~1.08 and the absolute difference of 0.0%p been distinguished?Required
The original effect is RR 1.00 (95% CI 0.92~1.08), with an original absolute difference of 0.0%p.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not create a new P value, absolute-difference CI, reverse-direction effect, risk example, NNT or exact equivalence. Model, adjustment and original denominator details have not been read.
Original RR, comparison direction, CI, absolute difference, model and test
Obtain the original effect of interest, model, test, denominators and interval.
9 Partly verified Full text not readStored summary read N09 · Comparative efficacyHas a null result been distinguished from the CI tail that leaves a small benefit possible?Required
The stored summary states that the CI lower bound of 0.92 leaves approximately 8% relative benefit possible, so absence of benefit is not established.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Preserve this wording as recorded; do not create new calculations, clinical margins, probabilities, an exact zero effect or an equivalence verdict.
Original interval, clinical importance, uncertainty and margin
Obtain original clinical boundaries, precision, analysis assumptions and interval.
10 Unverified Full text not readStored summary read N10 · Comparative efficacyHave the death and major-disability components and survivor assessment been separated?Required
The original materials provide the composite events and original proportions for death or major disability at age 2.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn the composite effect into separate mortality reduction, disability improvement or assessment of all survivors. Detailed component effects, group denominators, overlap, criteria and tests are absent.
Original events by component, people, survivor assessment, denominators and overlap
Obtain original events by component, survivors to be assessed, denominators, overlap and plans.
11 Partly verified Full text not readStored summary read N11 · Comparative efficacyWhat gaps remain in follow-up at age 2, age definition, missing data, loss to follow-up and proxy assessment?Required
The key outcome time is age 2. The stored summary preserves historical wording that evidence on assigned-group analysis and original missing data was reported.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly certify direct disability assessment of every infant, complete follow-up or absence of missing data solely from the total denominator. Original assessment-specific follow-up and handling details have not been read.
Assessment age, follow-up, visits, omissions, proxy or direct assessment and handling
Obtain original follow-up flow, age definition, omissions, assessment methods, handling and sensitivity analyses.
12 Partly verified Full text not readStored summary read N12 · Comparative efficacyHave allocation concealment, double blinding and the original listed-defect judgment been distinguished?Required
The stored summary preserves the history that listed defects were not counted because of original evidence on the international multicenter double-blind placebo control, allocation concealment, blinding, missing data and registration agreement.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not use this as certification that the present review passed or that no defects exist. Preserve parent B1 as recorded and do not reassess the axes.
Original allocation, concealment, blinding, assessment, analysis and reporting
Obtain original allocation, blinding, assessment, analysis, missing-data and reporting materials.
13 Partly verified Full text not readStored summary read N13 · Comparative efficacyWhat has actually been accessed for registration, the prespecified composite endpoint, multiplicity and the analysis hierarchy?Required
The recorded registration identifier is ISRCTN94984750, and the stored summary describes historical evidence of registration agreement.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Registration, full text and plans have not been newly read. Do not invent alpha, test P values, component hierarchies, subgroups, missing-data plans or changes.
Original registration, protocol, SAP, hierarchy, changes and analysis
Obtain original registration, plans, hierarchy, changes and analysis-population materials.
14 Unverified Full text not readStored summary read N14 · Comparative efficacyHave subgroups, other outcomes or mechanisms replaced the direct composite effect?Required
The stored summary records that the biological explanation of antibody deficiency did not translate into improved death or disability outcomes at age 2.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not fill composite events with mechanisms, subgroups lacking detail, short-term responses or prevention of all infections. There are no individual effects or suitability assessments, or new CIs or P values.
Prespecified subgroups, interactions, original denominators and clinical outcomes
Obtain original prespecified subgroups, interactions, denominators and direct outcomes.
15 Partly verified Full text not readStored summary read N15 · Comparative efficacyHave public funding, product provision, affiliations and external-analysis information been separated?Required
Preserve support from the UK's MRC, Australia's NHMRC and New Zealand's HRC as stated 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 newly extend public funding or original I2 into certification of no in-kind products, no company employees or independent analysis. Detailed roles and product supply have not been read.
Cash, IVIG or placebo provision, company affiliations, external analysis and study roles
Obtain original disclosures separately for funding, products or placebo, affiliations, design, analysis and writing.
16 Partly verified Full text not readStored summary read N16 · Supplementary harm evidenceHave 12 versus 10 adverse events and the included 2 versus 4 deaths been separated?Required
The original full-text adverse-event description is IVIG 12 events (including 2 deaths) versus placebo 10 events (including 4 deaths). These are adverse-event counts.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn these into 12/10 people, total deaths, components of the 686/677 composite events or drug-related deaths. Numbers of people, denominators, relatedness, overlap and collection details have not been read.
Adverse-event definitions, events versus people, relatedness, denominators and mapping of original deaths
Obtain original adverse-event counts and people, included deaths, denominators, relatedness, exposure and component mapping.
17 Partly verified Full text not readStored summary read N17 · Supplementary harm evidenceHas the absence of a reported adverse-event significance test been turned into a safety difference?Required
The stored review summary and safety description record that no original significance test was presented for the comparison of 12 versus 10 events.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not establish increased or decreased harm, equivalence or safety from the direction of event counts alone. There are no new P values, CIs, proportions, risk differences or hypothetical examples.
Original adverse-event plan, comparison, test, interval and denominators
Obtain original adverse-event plans, denominators, exposure, tests and intervals.
18 Unverified Full text not readStored summary read N18 · Supplementary harm evidenceHave exposure, discontinuation, rare or long-term harms and the age-2 outcome been separated?Required
The original materials preserve study administration conditions, AE counts and death or major disability at age 2; the parent safety status is Caution.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not replace missing AE collection, rare harms, long-term safety or administration completion with the original composite result. Do not create treatment, monitoring or administration instructions.
Harm collection, actual exposure, duration, denominators, relatedness and discontinuation
Obtain original safety-population, exposure, discontinuation, collection and long-term follow-up materials.
19 Unverified Full text not readStored summary read N19 · Supplementary harm evidenceHave prevention trials and other populations or products been distinguished from independent replication?Required
INIS concerns adjunctive treatment in neonates with sepsis receiving antibiotics, whereas verdict 2928 concerns preventing infection in extremely preterm infants using a different intervention.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not combine the two sheets, sites or composite components as independent replications of the same trial, product superiority or the same effect in every population. Independent counts and participant totals are not recorded.
Original question, timing, intervention, population and report or cohort relationships
Preserve direct outcomes for new populations, products or timing and the report or cohort relationships.
20 Partly verified Full text not readStored summary read N20 · Comparative efficacyDo gaps remain for outcomes beyond age 2 and applications to other indications?Required
The direct key outcome in the currently designated stored review summary is death or major disability at age 2.
R01
Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not extend this result to all IVIG indications, other ages or exposures, lifelong disability or survival, or prevention questions. There is no recommendation on use or suitability.
Direct comparisons of long-term components, other populations, other products and exposure
Obtain direct effect and harm materials by duration, population, product and exposure.
21 Partly verified Full text not readStored summary read N21 · 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
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.
22 Partly verified Full text not readStored summary read N22 · 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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22 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
INIS neonates receiving antibiotics for suspected or confirmed sepsis; original eligibility and baseline details not read
Ingredient, formulation and route
Historical adjunctive exposure to IVIG added to antibiotics; no recommendation to select or use it
Dose
The original 500mg/kg given twice 48 hours apart is preserved only as historical information; no individual administration, dosing or procedural guidance is created
Comparator
Placebo and antibiotics common to both groups; product and actual concomitant treatment or exposure details not read
Measured outcome
Death or major disability at age 2 as a composite; distinguish its components, survivor assessment and deaths included in adverse events
Duration
Composite assessment at age 2; age definition, follow-up and missing-data details not read; distinguish treatment exposure from follow-up
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 · INIS Collaborative Group. N Engl J Med. 2011;365:1201-1211. PMID: 21962214.

PubMed

Material type
Original trial paper report
Materials actually read
Summary read; external or linked material unread
Findings recorded in the stored summary
39.0% versus 39.0%; RR 1.00 (95% CI 0.92~1.08), absolute difference 0.0%p
Record level
Existing review summary; no comparison with the external original report
Study overlap and independent replication
The same INIS age-2 composite outcome, original components and adverse events; the family ID for the same infant cohort links relationships and does 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

Report counts versus independent study counts

The same INIS age-2 composite outcome, original components and adverse events; the family ID for the same infant cohort links relationships and does 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
Reduction in death or major disability
N02 · Who was the original population receiving antibiotics for suspected or confirmed sepsis?
Required materials and conditions
Original sepsis definition, eligibility, baseline, entry timing and denominators
Conditions for verification
Original sepsis definition, eligibility, baseline, entry 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
Reduction in death or major disability
N03 · What was the actual comparison of added IVIG versus placebo with antibiotics common to both groups?
Required materials and conditions
Original IVIG identity, placebo, common antibiotics, concomitant treatment and actual exposure
Conditions for verification
Original IVIG identity, placebo, common antibiotics, concomitant treatment 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
Reduction in death or major disability
N04 · Have the original administration exposure, actual completion and safety denominators been separated?
Required materials and conditions
Original study plan, actual administration, omissions, exposure and denominators
Conditions for verification
Original study plan, actual administration, omissions, exposure 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
Reduction in death or major disability
N05 · Have the 113 hospitals, 3,493 participants and analysis by assigned group been preserved?
Required materials and conditions
Original allocation, group denominators, analysis population, sites and missing data
Conditions for verification
Original allocation, group denominators, analysis population, sites and missing data
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
Reduction in death or major disability
N06 · What is the composite definition of death or major disability at age 2?
Required materials and conditions
Composite events, components, severity criteria, instruments, assessment timing and denominators
Conditions for verification
Composite events, components, severity criteria, instruments, assessment 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
Reduction in death or major disability
N07 · Have 686/1759, 677/1734 and the original 39.0% been preserved?
Required materials and conditions
Original group order, composite events, original denominators, people versus events and proportions
Conditions for verification
Original group order, composite events, original denominators, people versus events and proportions
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
Reduction in death or major disability
N08 · Have RR 1.00, 95% CI 0.92~1.08 and the absolute difference of 0.0%p been distinguished?
Required materials and conditions
Original RR, comparison direction, CI, absolute difference, model and test
Conditions for verification
Original RR, comparison direction, CI, absolute difference, model and test
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
Reduction in death or major disability
N09 · Has a null result been distinguished from the CI tail that leaves a small benefit possible?
Required materials and conditions
Original interval, clinical importance, uncertainty and margin
Conditions for verification
Original interval, clinical importance, uncertainty and margin
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
Reduction in death or major disability
N10 · Have the death and major-disability components and survivor assessment been separated?
Required materials and conditions
Original events by component, people, survivor assessment, denominators and overlap
Conditions for verification
Original events by component, people, survivor assessment, denominators and overlap
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
Reduction in death or major disability
N11 · What gaps remain in follow-up at age 2, age definition, missing data, loss to follow-up and proxy assessment?
Required materials and conditions
Assessment age, follow-up, visits, omissions, proxy or direct assessment and handling
Conditions for verification
Assessment age, follow-up, visits, omissions, proxy or direct assessment and handling
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
Reduction in death or major disability
N12 · Have allocation concealment, double blinding and the original listed-defect judgment been distinguished?
Required materials and conditions
Original allocation, concealment, blinding, assessment, analysis and reporting
Conditions for verification
Original allocation, concealment, blinding, assessment, analysis and reporting
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
Reduction in death or major disability
N13 · What has actually been accessed for registration, the prespecified composite endpoint, multiplicity and the analysis hierarchy?
Required materials and conditions
Original registration, protocol, SAP, hierarchy, changes and analysis
Conditions for verification
Original registration, protocol, SAP, hierarchy, changes and analysis
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
Reduction in death or major disability
N14 · Have subgroups, other outcomes or mechanisms replaced the direct composite effect?
Required materials and conditions
Prespecified subgroups, interactions, original denominators and clinical outcomes
Conditions for verification
Prespecified subgroups, interactions, original denominators and clinical outcomes
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
Reduction in death or major disability
N15 · Have public funding, product provision, affiliations and external-analysis information been separated?
Required materials and conditions
Cash, IVIG or placebo provision, company affiliations, external analysis and study roles
Conditions for verification
Cash, IVIG or placebo provision, company affiliations, external 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
Reduction in death or major disability
N16 · Have 12 versus 10 adverse events and the included 2 versus 4 deaths been separated?
Required materials and conditions
Adverse-event definitions, events versus people, relatedness, denominators and mapping of original deaths
Conditions for verification
Adverse-event definitions, events versus people, relatedness, denominators and mapping of original deaths
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
Reduction in death or major disability
N17 · Has the absence of a reported adverse-event significance test been turned into a safety difference?
Required materials and conditions
Original adverse-event plan, comparison, test, interval and denominators
Conditions for verification
Original adverse-event plan, comparison, test, interval 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
Reduction in death or major disability
N18 · Have exposure, discontinuation, rare or long-term harms and the age-2 outcome been separated?
Required materials and conditions
Harm collection, actual exposure, duration, denominators, relatedness and discontinuation
Conditions for verification
Harm collection, actual exposure, duration, denominators, 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
Reduction in death or major disability
N19 · Have prevention trials and other populations or products been distinguished from independent replication?
Required materials and conditions
Original question, timing, intervention, population and report or cohort relationships
Conditions for verification
Original question, timing, intervention, population and report or cohort relationships
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
Reduction in death or major disability
N20 · Do gaps remain for outcomes beyond age 2 and applications to other indications?
Required materials and conditions
Direct comparisons of long-term components, other populations, other products and exposure
Conditions for verification
Direct comparisons of long-term components, other populations, other products and 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
Reduction in death or major disability
N21 · 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
Reduction in death or major disability
N22 · 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
Reduction in death or major disability
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 is in the stored summary; detailed original material remains unverified. This does not certify 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 22 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 verdict concerns 'reduction in death or major disability', with subclaim grade D and the note 'RR was 1.00.'; the parent is D34 with Caution.
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
Reduction in death or major disability

Related sources R01

N02 · Who was the original population receiving antibiotics for suspected or confirmed sepsis?

Current findings
INIS asks about adjunctive IVIG in neonates already receiving antibiotics for suspected or confirmed 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. Do not combine this with trials of prevention before infection in extremely preterm infants. Original gestational age, birth weight, diagnostic or testing criteria and detailed eligibility have not been read.
Reason for missing information
Do not combine this with trials of prevention before infection in extremely preterm infants. Original gestational age, birth weight, diagnostic or testing criteria and detailed eligibility have not been read.
Required materials and conditions
Original sepsis definition, eligibility, baseline, entry timing and denominators
Materials to obtain first
Do not combine this with trials of prevention before infection in extremely preterm infants. Original gestational age, birth weight, diagnostic or testing criteria and detailed eligibility have not been read.
Further research
Obtain original population, diagnosis, eligibility, baseline and entry-timing materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original sepsis definition, eligibility, baseline, entry 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
Reduction in death or major disability

Related sources R01

N03 · What was the actual comparison of added IVIG versus placebo with antibiotics common to both groups?

Current findings
All infants received antibiotics, and the international double-blind RCT compared added IVIG with 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 turn this into IVIG alone, replacement of antibiotics or selection of a particular product. Placebo ingredients, the IVIG product and details of common antibiotics or treatment have not been read.
Reason for missing information
Do not turn this into IVIG alone, replacement of antibiotics or selection of a particular product. Placebo ingredients, the IVIG product and details of common antibiotics or treatment have not been read.
Required materials and conditions
Original IVIG identity, placebo, common antibiotics, concomitant treatment and actual exposure
Materials to obtain first
Do not turn this into IVIG alone, replacement of antibiotics or selection of a particular product. Placebo ingredients, the IVIG product and details of common antibiotics or treatment have not been read.
Further research
Obtain original product, placebo, common treatment, concomitant treatment and changes.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original IVIG identity, placebo, common antibiotics, concomitant treatment 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
Reduction in death or major disability

Related sources R01

N04 · Have the original administration exposure, actual completion and safety denominators been separated?

Current findings
The historical regimen in the review summary is IVIG 500mg/kg given twice, 48 hours apart.
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 create individual administration, dosing, infusion or suitability guidance. Detailed actual completion, placebo exposure, discontinuation and safety denominators have not been read.
Reason for missing information
Do not create individual administration, dosing, infusion or suitability guidance. Detailed actual completion, placebo exposure, discontinuation and safety denominators have not been read.
Required materials and conditions
Original study plan, actual administration, omissions, exposure and denominators
Materials to obtain first
Do not create individual administration, dosing, infusion or suitability guidance. Detailed actual completion, placebo exposure, discontinuation and safety denominators have not been read.
Further research
Obtain original tables of planned and actual administration, omissions, discontinuation and exposure.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original study plan, actual administration, omissions, exposure 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
Reduction in death or major disability

Related sources R01

N05 · Have the 113 hospitals, 3,493 participants and analysis by assigned group been preserved?

Current findings
The stored review summary states that 3,493 participants at 113 hospitals were randomized and analyzed by assigned group. Composite outcome denominators are 1,759/1,734.
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 multiple sites or denominators as independent trials. Do not invent group follow-up, omissions, imputation or exceptions, or certify completed disability assessment for everyone.
Reason for missing information
Do not count multiple sites or denominators as independent trials. Do not invent group follow-up, omissions, imputation or exceptions, or certify completed disability assessment for everyone.
Required materials and conditions
Original allocation, group denominators, analysis population, sites and missing data
Materials to obtain first
Do not count multiple sites or denominators as independent trials. Do not invent group follow-up, omissions, imputation or exceptions, or certify completed disability assessment for everyone.
Further research
Obtain original participant flow, analysis population, group denominators, follow-up and missing-data handling.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original allocation, group denominators, analysis population, sites and missing data
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
Reduction in death or major disability

Related sources R01

N06 · What is the composite definition of death or major disability at age 2?

Current findings
The original endpoint is death or major disability at age 2. Preserve the composite result within one selected question.
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 split components into new units or simply add them together. Details are absent on whether age 2 is corrected age, disability scales or criteria, assessors, methods and handling of overlap.
Reason for missing information
Do not split components into new units or simply add them together. Details are absent on whether age 2 is corrected age, disability scales or criteria, assessors, methods and handling of overlap.
Required materials and conditions
Composite events, components, severity criteria, instruments, assessment timing and denominators
Materials to obtain first
Do not split components into new units or simply add them together. Details are absent on whether age 2 is corrected age, disability scales or criteria, assessors, methods and handling of overlap.
Further research
Obtain the original composite definition, severity criteria, instruments, assessed population, timing and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Composite events, components, severity criteria, instruments, assessment 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
Reduction in death or major disability

Related sources R01

N07 · Have 686/1759, 677/1734 and the original 39.0% been preserved?

Current findings
Death or major disability at age 2 was IVIG 686/1759 (39.0%) versus placebo 677/1734 (39.0%).
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 equal rounded proportions into equality of every component or exact risks. Do not calculate event or participant totals, new proportions or group differences.
Reason for missing information
Do not turn equal rounded proportions into equality of every component or exact risks. Do not calculate event or participant totals, new proportions or group differences.
Required materials and conditions
Original group order, composite events, original denominators, people versus events and proportions
Materials to obtain first
Do not turn equal rounded proportions into equality of every component or exact risks. Do not calculate event or participant totals, new proportions or group differences.
Further research
Obtain original composite event tables, denominators, components, overlap and missing data.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original group order, composite events, original denominators, people versus events and proportions
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
Reduction in death or major disability

Related sources R01

N08 · Have RR 1.00, 95% CI 0.92~1.08 and the absolute difference of 0.0%p been distinguished?

Current findings
The original effect is RR 1.00 (95% CI 0.92~1.08), with an original absolute difference of 0.0%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 create a new P value, absolute-difference CI, reverse-direction effect, risk example, NNT or exact equivalence. Model, adjustment and original denominator details have not been read.
Reason for missing information
Do not create a new P value, absolute-difference CI, reverse-direction effect, risk example, NNT or exact equivalence. Model, adjustment and original denominator details have not been read.
Required materials and conditions
Original RR, comparison direction, CI, absolute difference, model and test
Materials to obtain first
Do not create a new P value, absolute-difference CI, reverse-direction effect, risk example, NNT or exact equivalence. Model, adjustment and original denominator details have not been read.
Further research
Obtain the original effect of interest, model, test, denominators and interval.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original RR, comparison direction, CI, absolute difference, model and test
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
Reduction in death or major disability

Related sources R01

N09 · Has a null result been distinguished from the CI tail that leaves a small benefit possible?

Current findings
The stored summary states that the CI lower bound of 0.92 leaves approximately 8% relative benefit possible, so absence of benefit is not established.
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. Preserve this wording as recorded; do not create new calculations, clinical margins, probabilities, an exact zero effect or an equivalence verdict.
Reason for missing information
Preserve this wording as recorded; do not create new calculations, clinical margins, probabilities, an exact zero effect or an equivalence verdict.
Required materials and conditions
Original interval, clinical importance, uncertainty and margin
Materials to obtain first
Preserve this wording as recorded; do not create new calculations, clinical margins, probabilities, an exact zero effect or an equivalence verdict.
Further research
Obtain original clinical boundaries, precision, analysis assumptions and interval.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original interval, clinical importance, uncertainty and margin
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
Reduction in death or major disability

Related sources R01

N10 · Have the death and major-disability components and survivor assessment been separated?

Current findings
The original materials provide the composite events and original proportions for death or major disability at age 2.
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 turn the composite effect into separate mortality reduction, disability improvement or assessment of all survivors. Detailed component effects, group denominators, overlap, criteria and tests are absent.
Reason for missing information
Do not turn the composite effect into separate mortality reduction, disability improvement or assessment of all survivors. Detailed component effects, group denominators, overlap, criteria and tests are absent.
Required materials and conditions
Original events by component, people, survivor assessment, denominators and overlap
Materials to obtain first
Do not turn the composite effect into separate mortality reduction, disability improvement or assessment of all survivors. Detailed component effects, group denominators, overlap, criteria and tests are absent.
Further research
Obtain original events by component, survivors to be assessed, denominators, overlap and plans.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original events by component, people, survivor assessment, denominators and overlap
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
Reduction in death or major disability

Related sources R01

N11 · What gaps remain in follow-up at age 2, age definition, missing data, loss to follow-up and proxy assessment?

Current findings
The key outcome time is age 2. The stored summary preserves historical wording that evidence on assigned-group analysis and original missing data was reported.
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 direct disability assessment of every infant, complete follow-up or absence of missing data solely from the total denominator. Original assessment-specific follow-up and handling details have not been read.
Reason for missing information
Do not newly certify direct disability assessment of every infant, complete follow-up or absence of missing data solely from the total denominator. Original assessment-specific follow-up and handling details have not been read.
Required materials and conditions
Assessment age, follow-up, visits, omissions, proxy or direct assessment and handling
Materials to obtain first
Do not newly certify direct disability assessment of every infant, complete follow-up or absence of missing data solely from the total denominator. Original assessment-specific follow-up and handling details have not been read.
Further research
Obtain original follow-up flow, age definition, omissions, assessment methods, handling and sensitivity analyses.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Assessment age, follow-up, visits, omissions, proxy or direct assessment and handling
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
Reduction in death or major disability

Related sources R01

N12 · Have allocation concealment, double blinding and the original listed-defect judgment been distinguished?

Current findings
The stored summary preserves the history that listed defects were not counted because of original evidence on the international multicenter double-blind placebo control, allocation concealment, blinding, missing data and registration agreement.
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 use this as certification that the present review passed or that no defects exist. Preserve parent B1 as recorded and do not reassess the axes.
Reason for missing information
Do not use this as certification that the present review passed or that no defects exist. Preserve parent B1 as recorded and do not reassess the axes.
Required materials and conditions
Original allocation, concealment, blinding, assessment, analysis and reporting
Materials to obtain first
Do not use this as certification that the present review passed or that no defects exist. Preserve parent B1 as recorded and do not reassess the axes.
Further research
Obtain original allocation, blinding, assessment, analysis, missing-data and reporting materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original allocation, concealment, blinding, assessment, analysis and reporting
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
Reduction in death or major disability

Related sources R01

N13 · What has actually been accessed for registration, the prespecified composite endpoint, multiplicity and the analysis hierarchy?

Current findings
The recorded registration identifier is ISRCTN94984750, and the stored summary describes historical evidence of registration agreement.
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. Registration, full text and plans have not been newly read. Do not invent alpha, test P values, component hierarchies, subgroups, missing-data plans or changes.
Reason for missing information
Registration, full text and plans have not been newly read. Do not invent alpha, test P values, component hierarchies, subgroups, missing-data plans or changes.
Required materials and conditions
Original registration, protocol, SAP, hierarchy, changes and analysis
Materials to obtain first
Registration, full text and plans have not been newly read. Do not invent alpha, test P values, component hierarchies, subgroups, missing-data plans or changes.
Further research
Obtain original registration, plans, hierarchy, changes and analysis-population materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original registration, protocol, SAP, hierarchy, changes and analysis
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
Reduction in death or major disability

Related sources R01

N14 · Have subgroups, other outcomes or mechanisms replaced the direct composite effect?

Current findings
The stored summary records that the biological explanation of antibody deficiency did not translate into improved death or disability outcomes at age 2.
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 fill composite events with mechanisms, subgroups lacking detail, short-term responses or prevention of all infections. There are no individual effects or suitability assessments, or new CIs or P values.
Reason for missing information
Do not fill composite events with mechanisms, subgroups lacking detail, short-term responses or prevention of all infections. There are no individual effects or suitability assessments, or new CIs or P values.
Required materials and conditions
Prespecified subgroups, interactions, original denominators and clinical outcomes
Materials to obtain first
Do not fill composite events with mechanisms, subgroups lacking detail, short-term responses or prevention of all infections. There are no individual effects or suitability assessments, or new CIs or P values.
Further research
Obtain original prespecified subgroups, interactions, denominators and direct outcomes.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Prespecified subgroups, interactions, original denominators and clinical outcomes
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
Reduction in death or major disability

Related sources R01

N15 · Have public funding, product provision, affiliations and external-analysis information been separated?

Current findings
Preserve support from the UK's MRC, Australia's NHMRC and New Zealand's HRC as stated 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 newly extend public funding or original I2 into certification of no in-kind products, no company employees or independent analysis. Detailed roles and product supply have not been read.
Reason for missing information
Do not newly extend public funding or original I2 into certification of no in-kind products, no company employees or independent analysis. Detailed roles and product supply have not been read.
Required materials and conditions
Cash, IVIG or placebo provision, company affiliations, external analysis and study roles
Materials to obtain first
Do not newly extend public funding or original I2 into certification of no in-kind products, no company employees or independent analysis. Detailed roles and product supply have not been read.
Further research
Obtain original disclosures separately for funding, products or placebo, affiliations, design, analysis and writing.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Cash, IVIG or placebo provision, company affiliations, external 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
Reduction in death or major disability

Related sources R01

N16 · Have 12 versus 10 adverse events and the included 2 versus 4 deaths been separated?

Current findings
The original full-text adverse-event description is IVIG 12 events (including 2 deaths) versus placebo 10 events (including 4 deaths). These are adverse-event counts.
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 these into 12/10 people, total deaths, components of the 686/677 composite events or drug-related deaths. Numbers of people, denominators, relatedness, overlap and collection details have not been read.
Reason for missing information
Do not turn these into 12/10 people, total deaths, components of the 686/677 composite events or drug-related deaths. Numbers of people, denominators, relatedness, overlap and collection details have not been read.
Required materials and conditions
Adverse-event definitions, events versus people, relatedness, denominators and mapping of original deaths
Materials to obtain first
Do not turn these into 12/10 people, total deaths, components of the 686/677 composite events or drug-related deaths. Numbers of people, denominators, relatedness, overlap and collection details have not been read.
Further research
Obtain original adverse-event counts and people, included deaths, denominators, relatedness, exposure and component mapping.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Adverse-event definitions, events versus people, relatedness, denominators and mapping of original deaths
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
Reduction in death or major disability

Related sources R01

N17 · Has the absence of a reported adverse-event significance test been turned into a safety difference?

Current findings
The stored review summary and safety description record that no original significance test was presented for the comparison of 12 versus 10 events.
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 establish increased or decreased harm, equivalence or safety from the direction of event counts alone. There are no new P values, CIs, proportions, risk differences or hypothetical examples.
Reason for missing information
Do not establish increased or decreased harm, equivalence or safety from the direction of event counts alone. There are no new P values, CIs, proportions, risk differences or hypothetical examples.
Required materials and conditions
Original adverse-event plan, comparison, test, interval and denominators
Materials to obtain first
Do not establish increased or decreased harm, equivalence or safety from the direction of event counts alone. There are no new P values, CIs, proportions, risk differences or hypothetical examples.
Further research
Obtain original adverse-event plans, denominators, exposure, tests and intervals.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original adverse-event plan, comparison, test, interval 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
Reduction in death or major disability

Related sources R01

N18 · Have exposure, discontinuation, rare or long-term harms and the age-2 outcome been separated?

Current findings
The original materials preserve study administration conditions, AE counts and death or major disability at age 2; the parent safety status is Caution.
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 replace missing AE collection, rare harms, long-term safety or administration completion with the original composite result. Do not create treatment, monitoring or administration instructions.
Reason for missing information
Do not replace missing AE collection, rare harms, long-term safety or administration completion with the original composite result. Do not create treatment, monitoring or administration instructions.
Required materials and conditions
Harm collection, actual exposure, duration, denominators, relatedness and discontinuation
Materials to obtain first
Do not replace missing AE collection, rare harms, long-term safety or administration completion with the original composite result. Do not create treatment, monitoring or administration instructions.
Further research
Obtain original safety-population, exposure, discontinuation, collection and long-term follow-up materials.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Harm collection, actual exposure, duration, denominators, 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
Reduction in death or major disability

Related sources R01

N19 · Have prevention trials and other populations or products been distinguished from independent replication?

Current findings
INIS concerns adjunctive treatment in neonates with sepsis receiving antibiotics, whereas verdict 2928 concerns preventing infection in extremely preterm infants using a different intervention.
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 combine the two sheets, sites or composite components as independent replications of the same trial, product superiority or the same effect in every population. Independent counts and participant totals are not recorded.
Reason for missing information
Do not combine the two sheets, sites or composite components as independent replications of the same trial, product superiority or the same effect in every population. Independent counts and participant totals are not recorded.
Required materials and conditions
Original question, timing, intervention, population and report or cohort relationships
Materials to obtain first
Do not combine the two sheets, sites or composite components as independent replications of the same trial, product superiority or the same effect in every population. Independent counts and participant totals are not recorded.
Further research
Preserve direct outcomes for new populations, products or timing and the report or cohort relationships.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original question, timing, intervention, population and report or cohort relationships
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
Reduction in death or major disability

Related sources R01

N20 · Do gaps remain for outcomes beyond age 2 and applications to other indications?

Current findings
The direct key outcome in the currently designated stored review summary is death or major disability at age 2.
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 this result to all IVIG indications, other ages or exposures, lifelong disability or survival, or prevention questions. There is no recommendation on use or suitability.
Reason for missing information
Do not extend this result to all IVIG indications, other ages or exposures, lifelong disability or survival, or prevention questions. There is no recommendation on use or suitability.
Required materials and conditions
Direct comparisons of long-term components, other populations, other products and exposure
Materials to obtain first
Do not extend this result to all IVIG indications, other ages or exposures, lifelong disability or survival, or prevention questions. There is no recommendation on use or suitability.
Further research
Obtain direct effect and harm materials by duration, population, product and exposure.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Direct comparisons of long-term components, other populations, other products and 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
Reduction in death or major disability

Related sources R01

N21 · 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
Reduction in death or major disability

Related sources R01

N22 · 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
Reduction in death or major disability

Related sources R01