{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "BBG-001 × prevention of NEC, sepsis and death in very preterm infants — three primary outcomes evidence sheet",
  "language": "en",
  "translation_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary, with detailed original materials still unverified; no certification of a passed review or clinical efficacy",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant condition's scope after user review; no automatic display in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Have the original subclaim verdict and the parent values and context been distinguished?",
      "needed": "Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link additional materials separately to the selected question and the parent context."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "Have the population and eligibility for prevention in very preterm infants been distinguished from adjunctive treatment?",
      "needed": "Gestational age, birth, recruitment, eligibility, baseline and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Gestational age, birth, recruitment, eligibility, baseline and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original eligibility, baseline, recruitment, timing and concomitant-exposure materials."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "What are the BBG-001 strain identity, placebo and actual exposure?",
      "needed": "Original strain, formulation, quality, control, administration duration and actual exposure",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original strain, formulation, quality, control, administration duration and actual exposure",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original strain, product, placebo, quality, duration and actual-exposure tables."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Have the 1,315 participants and group denominators for the three outcomes been distinguished?",
      "needed": "Original allocation, group analyses, missing data and event-specific denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original allocation, group analyses, missing data and event-specific denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original participant flow, group denominators for each outcome, omissions and event mapping."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Are sepsis, NEC and death before discharge a single composite event?",
      "needed": "Three co-primary outcomes, original definitions, individual people or events and time",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Three co-primary outcomes, original definitions, individual people or events and time",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original definition of each endpoint, prespecified hierarchy, overlap, denominators and timing."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What are the actual sepsis definition, confirmation and observation period?",
      "needed": "Sepsis definition, testing, confirmation, timing, people or events and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Sepsis definition, testing, confirmation, timing, people or events and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original sepsis definition, confirmation, timing, denominators and repeated-event tables."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Are the sepsis proportions, adjusted RR, 95% CI and original absolute difference preserved?",
      "needed": "Original group order, proportions, adjustment model, effect, CI and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original group order, proportions, adjustment model, effect, CI and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original event tables, group denominators, adjustment model, tests and CIs."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "What are the definition, classification and verification scope for Bell stage 2 or greater NEC?",
      "needed": "Original NEC classification, adjudication, timing and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original NEC classification, adjudication, timing and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original Bell definitions, adjudication, results by stage or timing and denominators."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Have the original NEC proportions, RR, interval and absolute difference been preserved exactly?",
      "needed": "Original group proportions, effects, intervals, denominators and tests",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original group proportions, effects, intervals, denominators and tests",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original NEC events, denominators, RR, interval, model and tests."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Has death before discharge been distinguished from deaths in other periods or from other causes?",
      "needed": "Death definition, time, cause, denominators and follow-up",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Death definition, time, cause, denominators and follow-up",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original death definitions, timing, causes, group denominators and follow-up materials."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Are the original death proportions, RR, interval and absolute difference preserved?",
      "needed": "Original group proportions, original effects, intervals, denominators and tests",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original group proportions, original effects, intervals, denominators and tests",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original death tables, denominators, effects, intervals, adjustment and tests."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Has the original null result been distinguished from CIs that leave both benefit and harm possible?",
      "needed": "Original intervals, precision and clinical importance for each outcome",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original intervals, precision and clinical importance for each outcome",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original effects, precision, clinical boundaries and denominators for each outcome."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "Have cross-colonization, within-group colonization and actual event effects been distinguished?",
      "needed": "Placebo-group colonization, timing, confirmation, actual exposure and prespecified analyses",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Placebo-group colonization, timing, confirmation, actual exposure and prespecified analyses",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original colonization confirmation, exposure, timing, denominators, prespecified analyses and sensitivity analyses."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "What gaps remain in double blinding, placebo and actual adjudication and analysis procedures?",
      "needed": "Original allocation, concealment, blinding, adjudicators and analysts",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original allocation, concealment, blinding, adjudicators and analysts",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original allocation, blinding, confirmation, analysis and missing-data procedures."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "What gaps remain in the prespecified hierarchy, multiple primary outcomes and registration access?",
      "needed": "Original registration, protocol, SAP, multiplicity, changes and analysis population",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original registration, protocol, SAP, multiplicity, changes and analysis population",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original registration, plans, hierarchy, multiplicity, analysis populations and changes."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "Have the single PiPS trial, multiple outcomes and related-verdict links been kept from being added as independent evidence?",
      "needed": "Relationships among the same trial, reports, cohort, outcomes and cross-citations",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Relationships among the same trial, reports, cohort, outcomes and cross-citations",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link additional reports by original identifiers, participants, outcomes and strain relationships."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Have the original cross-citation of the verdict 1503 strain combination and new direct evidence been separated?",
      "needed": "Existing related-verdict record, strains, population, trials and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Existing related-verdict record, strains, population, trials and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link relevant original materials provided by the user by strain, comparison and cohort."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Have NIHR cash funding, Yakult in-kind provision and study roles each been preserved?",
      "needed": "Funding, product or placebo manufacture, transport, affiliations, analysis and study roles",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Funding, product or placebo manufacture, transport, affiliations, analysis and study roles",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original disclosures on funding, in-kind provision, affiliations, design, conduct, analysis and writing."
    },
    {
      "item_id": "N19",
      "question_type": "Supplementary harm evidence",
      "question": "Have nonreporting of a probiotic-bacteremia signal and the original event intervals been separated?",
      "needed": "Harm definition, collection, people or events, exposure, denominators and relatedness",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Harm definition, collection, people or events, exposure, denominators and relatedness",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original harm collection, group events or people, denominators, relatedness, exposure and CIs."
    },
    {
      "item_id": "N20",
      "question_type": "Supplementary harm evidence",
      "question": "What gaps remain in exposure duration, missing data, safety-analysis populations and rare harms?",
      "needed": "Actual exposure, harm denominators, observation windows, relatedness and discontinuation",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Actual exposure, harm denominators, observation windows, relatedness and discontinuation",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original exposure, safety-analysis population, discontinuation, missing-data, follow-up and relatedness materials."
    },
    {
      "item_id": "N21",
      "question_type": "Supplementary harm evidence",
      "question": "Do gaps remain when applying effects or harms to other populations, strains, combinations or durations?",
      "needed": "Direct comparisons and independent relationships by population, strain, formulation and duration",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Direct comparisons and independent relationships by population, strain, formulation and duration",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain direct effect and harm materials by population, strain, combination and duration."
    },
    {
      "item_id": "N22",
      "question_type": "Comparative efficacy",
      "question": "Are the stored summary, original URLs, registration identifier and access to linked targets distinguished?",
      "needed": "Reports or cross-citations, URLs, identifiers and access by material",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Reports or cross-citations, URLs, identifiers and access by material",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link user-provided original materials to each material type and access status."
    },
    {
      "item_id": "N23",
      "question_type": "Comparative efficacy",
      "question": "Have the Korean and English manuscripts, original axes, dates, corrections, empty values, candidate history and preparation status been preserved?",
      "needed": "Distinguish the selected verdict record, complete parent, original languages and history from current preparation",
      "role": "Supplementary",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Distinguish the selected verdict record, complete parent, original languages and history from current preparation",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Preserve user materials and decisions in full, then link them as separate events."
    }
  ]
}