Kaimen Rigor reviewed

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Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).

Name: Kaimen Rigor review — Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).
Item: Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).
Rating: 96
Author: Alpha1

Adhisivam B, Kamalarathnam C, Bhat BV, Jayaraman K, Namachivayam SP, Shann F, McSharry B, David P, Raja, Sundaram M

Paper source

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Kaimen Rigor review — 2.75★ (Weak), 0 critical, 2 high issues for “Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).

Adhisivam B, Kamalarathnam C, Bhat BV, Jayaraman K, Namachivayam SP, Shann F, McSharry B, David P, Raja, Sundaram M

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DOI

10.1136/bmj-2025-084745

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).

Adhisivam B, Kamalarathnam C, Bhat BV, Jayaraman K, Namachivayam SP, Shann F, McSharry B, David P, Raja, Sundaram M

Paper source

Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsOverstated claim−0.5★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 4 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues

01Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
A substantial reduction in neonatal mortality could be achieved if a skilled administrator vaccinated a high proportion of newborns soon after birth.
“A substantial reduction in neonatal mortality could be achieved if a skilled administrator vaccinated a high proportion of newborn babies in high mortality settings on the day of, or soon after, birth.”
ConclusionFind in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit5 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and transparently reported randomised controlled trial with a strong scientific premise, rigorous design, and appropriate statistical analysis. The main weakness is the vague data availability statement, which lacks a concrete access mechanism or repository deposit, and the absence of an explicit reporting guideline checklist.

Both reviewers independently scored all eight dimensions and agreed on every status; no divergence required reconciliation. The study is an interventional RCT; non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification recomputed only 2 reported tests (both consistent); other statistics were not machine-verified and should not be assumed correct beyond that.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 2 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 1 via agent-written checks.

Overstated conclusions

1 finding · worst medium

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions overstated beyond the evidenceAssessed

4 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

The introduction cites prior randomised trials in Guinea-Bissau and the authors' own BLOW1 trials, acknowledging conflicting results and the need to test a different BCG strain. The rationale for using BCG Danish and OPV is clearly linked to the hypothesis that non-specific effects may reduce neonatal mortality. The paper explicitly addresses limitations of prior research, such as the different BCG strains and the need for a larger trial.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a strong scientific premise by citing prior trials and meta-analyses, providing a logical rationale for the study, and addressing limitations of prior research.

Evidence

“In three randomised trials in newborns weighing <2500 g in Guinea-Bissau, none had a statistically significant effect on the primary outcome from the administration of BCG Danish vaccine (Statens Serum Institut, Copenhagen) at discharge from hospital, but meta-analysis showed a reduction in neonatal mortality of 38% (95% CI 17% to 54%)”

Introduction ¶3Find in source

“The four strains of BCG that Unicef distributes to low and middle income countries differ noticeably in bacterial viability, RNA content, and immunological effects, and the vaccines might therefore have different specific and non-specific effects.”

Introduction ¶4Find in source

“Our trial differs in important ways from the four other smaller randomised trials with an unvaccinated control group that tested the effect of BCG Danish on neonatal mortality in Guinea-Bissau.”

DiscussionFind in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research on BCG's non-specific effects and the conflicting results from previous trials, and it provides a logical rationale for testing BCG Danish in this population.

Evidence

Introduction ¶2Find in source

“Soon after completion of our trials of BCG Russian, and because this vaccine may be less effective than BCG Danish, we performed a trial in newborn babies weighing <2000 g (BLOW2) to test the effect of BCG Danish and OPV in the same three NICUs that had tested BCG Russian using the same trial design.”

Introduction ¶4Find in source

“In three randomised trials in newborns weighing <2500 g in Guinea-Bissau, none had a statistically significant effect on the primary outcome”

Introduction ¶3Find in source

Randomisation was computer-generated, 1:1, stratified by NICU, sex, and birth weight, with random block sizes. A priori sample size calculation was based on expected mortality and a 30% reduction. Inclusion/exclusion criteria were pre-specified. Blinding was not possible due to the visible BCG scar, and this was explicitly justified. The analysis population (ITT) and handling of missing data (censoring) were defined.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with clear randomisation, stratification, sample size calculation, and pre-specified inclusion/exclusion criteria. Blinding was not feasible and was justified.

Evidence

“The newborn babies were randomised using a specially written computer program that checked eligibility, allocated treatment, and recorded baseline and outcome data. Randomisation was 1:1 and stratified by NICU, sex, and birth weight (<1000 g, 1000-1499 g, 1500-1999 g), and with a block size that varied randomly from 2-8 newborn babies.”

MethodsFind in source

“using the Stata version 14.1 sampsi command, we estimated that a total of 510 deaths would be required: with a mortality rate of 15% in the control group, 1998 infants would be required in each group to have 95% power to detect a 30% reduction in mortality using BCG and OPV with an α <0.01”

MethodsFind in source

“The BCG vaccine causes an obvious skin lesion, so it was not possible to mask staff to group assignment because it would have been unethical to cover the upper arm of these high risk babies for their entire stay in intensive care”

MethodsFind in source

PASSReviewer 2· 90% conf

The trial design is rigorous: randomization method and unit are described, sample size is justified, inclusion/exclusion criteria are pre-specified, and the lack of blinding is explained. The analysis population and missing-data approach are defined.

Evidence

MethodsFind in source

“we estimated that a total of 510 deaths would be required: with a mortality rate of 15% in the control group, 1998 infants would be required in each group to have 95% power to detect a 30% reduction in mortality using BCG and OPV with an α <0.01”

MethodsFind in source

Sex, birth weight, gestational age, and other baseline characteristics are reported in Table 1. The study includes both sexes, so sex justification is not applicable. Age (at enrolment) and health status (prematurity, Apgar scores) are reported. Demographics such as maternal BCG scar and delivery mode are also reported.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Key biological variables (sex, birth weight, gestational age) are reported in baseline characteristics. Demographics are reported for this human trial.

Evidence

paraphrase[Table 1]

“Sex: Male 1389 (51) | 1382 (51); Female 1325 (49) | 1324 (49)”

paraphrase[Table 1]

“Median (IQR) age at enrolment (days) 0.86 (0.54-1.46) | 0.86 (0.56-1.38)”

paraphrase[Table 1]

“Maternal BCG scar 1601 (59) | 1658 (61); Vaginal delivery 1523 (56) | 1476 (55)”

PASSReviewer 2· 90% conf

Biological variables are well reported: sex, birth weight, gestational age, and other baseline characteristics are provided for both groups. Demographics are reported in detail.

Evidence

“Male | 1389 (51) | 1382 (51) | | Female | 1325 (49) | 1324 (49)”

Table 1Find in source

“Median (IQR) age at enrolment (days) | 0.86 (0.54-1.46) | 0.86 (0.56-1.38) | | Median (IQR) birth weight (g) | 1560 (1320-1745) | 1560 (1320-1745)”

Table 1Find in source

paraphrase[Table 1]

“Premature (<37 week) | 2374 (87) | 2349 (87) | | Mean (SD) Apgar score: | 1 minute | 6.71 (1.52) | 6.76 (1.48)”

The paper states approval by the Jawaharlal Institute Ethics Committee and the Institutional Ethics Committee of Madras Medical College, with protocol numbers. Written informed consent was obtained from parents. The trial was registered prospectively.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from named ethics committees and informed consent are documented.

Evidence

“the trial was approved by the Jawaharlal Institute of Postgraduate Medical Education and Research Ethics and Scientific Advisory Committees (JIP/IEC/2016/25/831), and for the Institute of Child Health and Institute of Obstetrics and Gynaecology by the Institutional Ethics Committee of the Madras Medical College (No 02052018).”

EthicsFind in source

“Written informed consent was obtained from a parent before enrolment.”

MethodsFind in source

“Trial registration Clinical Trials Registry India CTRI/2017/01/007676.”

AbstractFind in source

PASSReviewer 2· 95% conf

Ethical approvals are clearly documented: named ethics committees approved the trial, informed consent was obtained, and regulatory compliance is stated.

Evidence

EthicsFind in source

“Written informed consent was obtained from a parent before enrolment.”

MethodsFind in source

“The protocol was registered prospectively with the Clinical Trials Registry India (CTRI/2017/01/007676).”

EthicsFind in source

The BCG Danish vaccine (GreenSignal Bio Pharma, Chennai) and OPV (Bharat Biotech International, Hyderabad; or Bio-Med, Ghaziabad) are named with manufacturers. The dose and route are specified. Stata version 18 is identified for analysis. No other key biological resources (antibodies, cell lines) are used.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational products (BCG Danish and OPV) are identified with manufacturers, and the statistical software is identified.

Evidence

“Babies in the early vaccination group received 0.1 mL of BCG Danish (GreenSignal Bio Pharma, Chennai) intradermally within 48 hours of admission to the NICU, along with 0.1 mL (two drops) of bivalent 1&3 OPV (Bharat Biotech International, Hyderabad; or Bio-Med, Ghaziabad).”

MethodsFind in source

“Intention-to-treat analysis was performed using Stata version 18”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational products (BCG Danish and OPV) are identified with manufacturers, and the statistical software is identified. Other bench resources are not applicable.

Evidence

MethodsFind in source

“Intention-to-treat analysis was performed using Stata version 18”

Statistical analysisFind in source

Cox proportional hazards models are used, with tests for proportional hazards and fractional polynomials for continuous variables. Exact p-values are reported (e.g., P=0.03). Effect sizes are reported as hazard ratios with 95% CIs. Statistical software (Stata 18) is identified. Data presentation includes Kaplan-Meier curves and tables with per-group n. The mathematical plausibility checks are not applicable due to large N and continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals. The analysis is consistent with clinical trial reporting standards.

Evidence

“The proportional hazards assumption of the Cox model was tested using Stata’s time-dependent covariable command with log(time), and by using Schoenfeld residuals, log-log plots, and separately estimated Kaplan-Meier curves.”

Statistical analysisFind in source

“adjusted hazard ratio 0.83, 95% confidence interval (CI) 0.69 to 0.98; P=0.03”

AbstractFind in source

“0.83 (0.69 to 0.98) | 0.03”

Table 2Find in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described: tests are named, assumptions are checked, effect sizes with CIs are reported, and software is identified. The trial reports by estimation with CIs and p-values, and the primary outcome is adequately presented.

Evidence

“Intention-to-treat analysis was performed using Stata version 18, with Cox proportional hazard models stratified by NICU with age as the underlying time”

Statistical analysisFind in source

“adjusted hazard ratio 0.83, 95% confidence interval (CI) 0.69 to 0.98; P=0.03”

AbstractFind in source

The data availability statement says 'Deidentified individual patient data are available on reasonable request' but does not specify a platform or conditions. The Stata analysis code is included in the supplementary file, which is a form of code sharing. No repository deposit or accession numbers are provided.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, and no repository deposit or accession numbers are provided. The statistical code is included in the supplementary file.

Evidence

paraphrase[Data availability statement]

“Deidentified individual patient data are available on reasonable request”

“The Stata statistical analysis code is included in the supplementary file.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

A data availability statement is present but vague: it mentions deidentified individual patient data but does not specify a concrete access mechanism or repository. The statistical code is included in the supplementary file.

Evidence

paraphrase[Data availability statement]

“Deidentified individual patient data”

“The Stata statistical analysis code is included in the supplementary file.”

Data availabilityFind in source

The trial is registered with CTRI. Methods are detailed enough for replication. Limitations, including lack of blinding and the secondary outcome added mid-trial, are discussed. Conclusions are appropriately cautious, noting the non-specific effect. Funding and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional. Funding and competing interests are declared.

Evidence

“Trial registration Clinical Trials Registry India CTRI/2017/01/007676.”

AbstractFind in source

“As skin lesions due to BCG are obvious, a double blind trial could not be performed as it was not ethical to keep the upper arm of these high risk babies covered during their entire stay in intensive care.”

DiscussionFind in source

“Funding: No external funding; the trial was supported by the participating units and the resources of the investigators. Competing interests: All authors have completed the ICMJE uniform disclosure form”

FundingFind in source

PASSReviewer 2· 90% conf

The manuscript is transparent: methods are detailed, the trial is registered, limitations are discussed, conclusions are proportional, and funding/COI are declared. A reporting guideline is not explicitly mentioned.

Evidence

“Trial registration Clinical Trials Registry India CTRI/2017/01/007676.”

AbstractFind in source

DiscussionFind in source

FundingFind in source

Registered (1 ID: Clinical Trials Registry – India). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 37 references by DOI: 29 verified — 8 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, clarity, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and generally trustworthy, with minor reporting gaps. An informed reader should weigh the vague data availability statement and the lack of an explicit CONSORT checklist; these do not undermine the core findings but warrant attention if the authors issue a correction or update.

1.
HIGHdata code
In the Data availability statement, specify a concrete access mechanism (e.g., a data access committee, a repository like OSF/Dryad/Zenodo with a DOI, or a clear process for requesting data from the corresponding author) and complete the sentence that currently reads 'Deidentified individual patient data'.
The current statement is vague and incomplete, which undermines reproducibility and transparency.
2.
HIGHreporting
Add an explicit statement in the Methods or a separate section that the trial adheres to the CONSORT reporting guideline, and consider uploading the CONSORT checklist as a supplementary file.
Reporting guidelines improve completeness and are expected for RCTs; the paper currently does not mention one.
3.
MEDIUMreporting
In the Discussion, explicitly note that the 95% CIs and P values for secondary outcomes were not adjusted for multiplicity, and discuss this as a limitation.
The copyedit flagged this as a clarity issue; readers should be aware of the potential for inflated type I error.
4.
MEDIUMcopyedit
In Table 1, replace the abbreviation 'JIMPER' with 'JIPMER' for consistency with the rest of the manuscript.
Inconsistent abbreviation for the same institution could confuse readers.
5.
MEDIUMcopyedit
In Table 4, clarify the column header 'BCG to control ratio' to indicate it is a crude ratio, not an adjusted hazard ratio, or add a footnote to that effect.
The copyedit noted the header could be misinterpreted; clarity improves accuracy.
6.
MEDIUMreporting
In the Discussion, temper the policy implication that 'a substantial reduction in neonatal mortality could be achieved if a skilled administrator vaccinated a high proportion of newborns soon after birth' to acknowledge it is an extrapolation not directly tested in this trial.
The claim audit rated this as overstated; the evidence supports a reduction in this trial but not a broad policy claim.
7.
LOWcopyedit
In the Abstract and Results, ensure the number needed to treat (NNT) of 21 (95% CI 10 to 245) is consistently reported and consider discussing the wide confidence interval.
The copyedit flagged a consistency issue; the wide CI is important for interpretation.
8.
LOWdata code
Consider depositing deidentified individual patient data in a public repository (e.g., Dryad, Zenodo) with a DOI, if ethically permissible, to enhance transparency.
A repository deposit would strengthen the data availability statement and support reproducibility.

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Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).

Adhisivam B, Kamalarathnam C, Bhat BV, Jayaraman K, Namachivayam SP, Shann F, McSharry B, David P, Raja, Sundaram M

Read full text (PMC)

DOI

10.1136/bmj-2025-084745

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Record fingerprint

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Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsOverstated claim−0.5★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 4 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues

01Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
A substantial reduction in neonatal mortality could be achieved if a skilled administrator vaccinated a high proportion of newborns soon after birth.
“A substantial reduction in neonatal mortality could be achieved if a skilled administrator vaccinated a high proportion of newborn babies in high mortality settings on the day of, or soon after, birth.”
ConclusionFind in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit5 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 2 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 1 via agent-written checks.

Overstated conclusions

1 finding · worst medium

Conclusions overstated beyond the evidenceAssessed

4 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a strong scientific premise by citing prior trials and meta-analyses, providing a logical rationale for the study, and addressing limitations of prior research.

Evidence

Introduction ¶3Find in source

Introduction ¶4Find in source

“Our trial differs in important ways from the four other smaller randomised trials with an unvaccinated control group that tested the effect of BCG Danish on neonatal mortality in Guinea-Bissau.”

DiscussionFind in source

PASSReviewer 2· 90% conf

Evidence

Introduction ¶2Find in source

Introduction ¶4Find in source

“In three randomised trials in newborns weighing <2500 g in Guinea-Bissau, none had a statistically significant effect on the primary outcome”

Introduction ¶3Find in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with clear randomisation, stratification, sample size calculation, and pre-specified inclusion/exclusion criteria. Blinding was not feasible and was justified.

Evidence

MethodsFind in source

PASSReviewer 2· 90% conf

Evidence

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Key biological variables (sex, birth weight, gestational age) are reported in baseline characteristics. Demographics are reported for this human trial.

Evidence

paraphrase[Table 1]

“Sex: Male 1389 (51) | 1382 (51); Female 1325 (49) | 1324 (49)”

paraphrase[Table 1]

“Median (IQR) age at enrolment (days) 0.86 (0.54-1.46) | 0.86 (0.56-1.38)”

paraphrase[Table 1]

“Maternal BCG scar 1601 (59) | 1658 (61); Vaginal delivery 1523 (56) | 1476 (55)”

PASSReviewer 2· 90% conf

Biological variables are well reported: sex, birth weight, gestational age, and other baseline characteristics are provided for both groups. Demographics are reported in detail.

Evidence

“Male | 1389 (51) | 1382 (51) | | Female | 1325 (49) | 1324 (49)”

Table 1Find in source

“Median (IQR) age at enrolment (days) | 0.86 (0.54-1.46) | 0.86 (0.56-1.38) | | Median (IQR) birth weight (g) | 1560 (1320-1745) | 1560 (1320-1745)”

Table 1Find in source

paraphrase[Table 1]

“Premature (<37 week) | 2374 (87) | 2349 (87) | | Mean (SD) Apgar score: | 1 minute | 6.71 (1.52) | 6.76 (1.48)”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from named ethics committees and informed consent are documented.

Evidence

EthicsFind in source

“Written informed consent was obtained from a parent before enrolment.”

MethodsFind in source

“Trial registration Clinical Trials Registry India CTRI/2017/01/007676.”

AbstractFind in source

PASSReviewer 2· 95% conf

Ethical approvals are clearly documented: named ethics committees approved the trial, informed consent was obtained, and regulatory compliance is stated.

Evidence

EthicsFind in source

“Written informed consent was obtained from a parent before enrolment.”

MethodsFind in source

“The protocol was registered prospectively with the Clinical Trials Registry India (CTRI/2017/01/007676).”

EthicsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational products (BCG Danish and OPV) are identified with manufacturers, and the statistical software is identified.

Evidence

MethodsFind in source

“Intention-to-treat analysis was performed using Stata version 18”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational products (BCG Danish and OPV) are identified with manufacturers, and the statistical software is identified. Other bench resources are not applicable.

Evidence

MethodsFind in source

“Intention-to-treat analysis was performed using Stata version 18”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals. The analysis is consistent with clinical trial reporting standards.

Evidence

Statistical analysisFind in source

“adjusted hazard ratio 0.83, 95% confidence interval (CI) 0.69 to 0.98; P=0.03”

AbstractFind in source

“0.83 (0.69 to 0.98) | 0.03”

Table 2Find in source

PASSReviewer 2· 90% conf

Evidence

“Intention-to-treat analysis was performed using Stata version 18, with Cox proportional hazard models stratified by NICU with age as the underlying time”

Statistical analysisFind in source

“adjusted hazard ratio 0.83, 95% confidence interval (CI) 0.69 to 0.98; P=0.03”

AbstractFind in source

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, and no repository deposit or accession numbers are provided. The statistical code is included in the supplementary file.

Evidence

paraphrase[Data availability statement]

“Deidentified individual patient data are available on reasonable request”

“The Stata statistical analysis code is included in the supplementary file.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

Evidence

paraphrase[Data availability statement]

“Deidentified individual patient data”

“The Stata statistical analysis code is included in the supplementary file.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional. Funding and competing interests are declared.

Evidence

“Trial registration Clinical Trials Registry India CTRI/2017/01/007676.”

AbstractFind in source

DiscussionFind in source

FundingFind in source

PASSReviewer 2· 90% conf

Evidence

“Trial registration Clinical Trials Registry India CTRI/2017/01/007676.”

AbstractFind in source

DiscussionFind in source

FundingFind in source

Registered (1 ID: Clinical Trials Registry – India). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 37 references by DOI: 29 verified — 8 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, clarity, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
In the Data availability statement, specify a concrete access mechanism (e.g., a data access committee, a repository like OSF/Dryad/Zenodo with a DOI, or a clear process for requesting data from the corresponding author) and complete the sentence that currently reads 'Deidentified individual patient data'.
The current statement is vague and incomplete, which undermines reproducibility and transparency.
2.
HIGHreporting
Add an explicit statement in the Methods or a separate section that the trial adheres to the CONSORT reporting guideline, and consider uploading the CONSORT checklist as a supplementary file.
Reporting guidelines improve completeness and are expected for RCTs; the paper currently does not mention one.
3.
MEDIUMreporting
In the Discussion, explicitly note that the 95% CIs and P values for secondary outcomes were not adjusted for multiplicity, and discuss this as a limitation.
The copyedit flagged this as a clarity issue; readers should be aware of the potential for inflated type I error.
4.
MEDIUMcopyedit
In Table 1, replace the abbreviation 'JIMPER' with 'JIPMER' for consistency with the rest of the manuscript.
Inconsistent abbreviation for the same institution could confuse readers.
5.
MEDIUMcopyedit
In Table 4, clarify the column header 'BCG to control ratio' to indicate it is a crude ratio, not an adjusted hazard ratio, or add a footnote to that effect.
The copyedit noted the header could be misinterpreted; clarity improves accuracy.
6.
MEDIUMreporting
In the Discussion, temper the policy implication that 'a substantial reduction in neonatal mortality could be achieved if a skilled administrator vaccinated a high proportion of newborns soon after birth' to acknowledge it is an extrapolation not directly tested in this trial.
The claim audit rated this as overstated; the evidence supports a reduction in this trial but not a broad policy claim.
7.
LOWcopyedit
In the Abstract and Results, ensure the number needed to treat (NNT) of 21 (95% CI 10 to 245) is consistently reported and consider discussing the wide confidence interval.
The copyedit flagged a consistency issue; the wide CI is important for interpretation.
8.
LOWdata code
Consider depositing deidentified individual patient data in a public repository (e.g., Dryad, Zenodo) with a DOI, if ethically permissible, to enhance transparency.
A repository deposit would strengthen the data availability statement and support reproducibility.

Full text (47,064 chars)Analyzed: Aug 15, 2026