# Adjunctive intravenous immunoglobulin × death or major disability at age 2 in neonates — composite outcome evidence sheet Verdict 2927 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-10 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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 ## Checklist items ### N01 · Have the original subclaim verdict and the parent values and context been distinguished? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Reduction in death or major disability - Related sources: R01 ### N02 · Who was the original population receiving antibiotics for suspected or confirmed sepsis? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - Current findings: INIS asks about adjunctive IVIG in neonates already receiving antibiotics for suspected or confirmed sepsis. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - Current findings: All infants received antibiotics, and the international double-blind RCT compared added IVIG with placebo. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Reduction in death or major disability - Related sources: R01 ### N04 · Have the original administration exposure, actual completion and safety denominators been separated? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - Current findings: The historical regimen in the review summary is IVIG 500mg/kg given twice, 48 hours apart. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - Current findings: The original endpoint is death or major disability at age 2. Preserve the composite result within one selected question. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Reduction in death or major disability - Related sources: R01 ### N07 · Have 686/1759, 677/1734 and the original 39.0% been preserved? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - Current findings: Death or major disability at age 2 was IVIG 686/1759 (39.0%) versus placebo 677/1734 (39.0%). - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - Current findings: The original effect is RR 1.00 (95% CI 0.92~1.08), with an original absolute difference of 0.0%p. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Reduction in death or major disability - Related sources: R01 ### N10 · Have the death and major-disability components and survivor assessment been separated? Verification status: Unverified Reading scope: Summary read; external or linked material unread - Current findings: The original materials provide the composite events and original proportions for death or major disability at age 2. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - Current findings: The recorded registration identifier is ISRCTN94984750, and the stored summary describes historical evidence of registration agreement. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Reduction in death or major disability - Related sources: R01 ### N14 · Have subgroups, other outcomes or mechanisms replaced the direct composite effect? Verification status: Unverified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Reduction in death or major disability - Related sources: R01 ### N15 · Have public funding, product provision, affiliations and external-analysis information been separated? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - Current findings: Preserve support from the UK's MRC, Australia's NHMRC and New Zealand's HRC as stated in the stored review summary. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Unverified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Unverified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - Current findings: The direct key outcome in the currently designated stored review summary is death or major disability at age 2. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external or linked material unread - 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. - 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. - 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. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Reduction in death or major disability - Related sources: R01 ## Evidence and sources ### R01 INIS Collaborative Group. N Engl J Med. 2011;365:1201-1211. PMID: 21962214. [PubMed](https://pubmed.ncbi.nlm.nih.gov/21962214/) Materials actually read: Summary read; external or linked material unread Findings recorded in the 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 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 | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | local_summary | Original URL preserved | Summary read | Summary read | Preserved parent verdict summary; report-specific links to the same stored summary copy | | abstract | Original URL preserved | Not read | Not read | External or linked verdict material unread; a URL does not mean reading or review is complete | | fulltext | No separate URL in the original material | Not read | Not read | External or linked verdict material unread; a URL does not mean reading or review is complete | | registration | No separate URL in the original material | Not read | Not read | External or linked verdict material unread; a URL does not mean reading or review is complete | | protocol_sap | No separate URL in the original material | Not read | Not read | External or linked verdict material unread; a URL does not mean reading or review is complete | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.