Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.

Name: Kaimen Rigor review — Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.
Item: Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.
Rating: 96
Author: Alpha1

Gupta S, Subhedar NV, Bell JL, Field D, Bowler U, Hutchison E, Johnson S, Kelsall W, Pepperell J, Roberts T, Sinha S, Stanbury K, Wyllie J, Hardy P, Juszczak E, Baby-OSCAR Collaborative Group

Paper source

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Kaimen Rigor review — 4.75★ (Strong), 0 critical, 2 high issues for “Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.

Gupta S, Subhedar NV, Bell JL, Field D, Bowler U, Hutchison E, Johnson S, Kelsall W, Pepperell J, Roberts T, Sinha S, Stanbury K, Wyllie J, Hardy P, Juszczak E, Baby-OSCAR Collaborative Group

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DOI

10.1056/NEJMoa2305582

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Issued Aug 16, 2026Engine 7.39.0

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.

Gupta S, Subhedar NV, Bell JL, Field D, Bowler U, Hutchison E, Johnson S, Kelsall W, Pepperell J, Roberts T, Sinha S, Stanbury K, Wyllie J, Hardy P, Juszczak E, Baby-OSCAR Collaborative Group

Paper source

Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

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: 8 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.
No data or code availability links were detected to verify.

Findings by category

01ArithmeticNone found 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit2 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 multicenter RCT with rigorous randomization, blinding, and statistical methods. The main weaknesses are the absence of a data availability statement and the lack of explicit ethics committee identification, both of which are reporting gaps rather than substantive flaws.

Both reviewers classified the study as interventional, and no divergence was noted. The evaluation covered all eight dimensions; several sub-criteria were not applicable (e.g., animal-related, cell line, housing). The statistics verification covered only 2 tests, so the statistical analysis is not fully verified.

Numerical inconsistencies

None found

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.

Checked — nothing surfaced.

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.

Overstated conclusions

None found

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.

Checked — nothing surfaced.

6 major claims checked against the paper's own evidence: all adequately supported.

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 research on PDA management, including prophylaxis and symptomatic treatment, and notes limitations such as unnecessary treatment and lack of outcome improvement. The hypothesis follows logically from the cited evidence that large PDAs are associated with worse outcomes and that selective early treatment may avoid unnecessary treatment.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes the scientific premise with prior work and a logical rationale for the hypothesis.

Evidence

“Prophylaxis with indomethacin or ibuprofen in the first 12 to 24 hours of life is reported to reduce severe intraventricular hemorrhage and pulmonary hemorrhage, but without an improvement in survival without neurosensory impairment at 18 months.”

Introduction ¶1Find in source

“We hypothesized that early (up to 72 hours) selective treatment of patients who have a PDA that is 1.5 mm diameter or larger with unrestricted flow, identified using bedside echocardiography, with ibuprofen compared to placebo, would reduce mortality and improve short-term outcomes such as BPD.”

Introduction ¶4Find in source

“However, utilizing a prophylactic approach, most infants will receive treatment unnecessarily since PDAs can close spontaneously.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the hypothesis.

Evidence

Introduction ¶2Find in source

IntroductionFind in source

“However, utilizing a prophylactic approach, most infants will receive treatment unnecessarily since PDAs can close spontaneously.”

Introduction ¶2Find in source

The trial is a multicenter, randomized, double-blind, placebo-controlled design with a web-based randomization system using minimization to balance key factors. Blinding of clinicians, families, and outcome assessors is described. A sample size calculation was performed, though the target was not reached. Inclusion/exclusion criteria are pre-specified, and the analysis population (ITT) and missing data handling are defined. The trial is registered and follows a published protocol.

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 proper randomization, blinding, and pre-specified analysis, though the sample size was not met.

Evidence

“Dynamic assignment to treatment group was performed via a secure web-based randomization system that was created and hosted by the NPEU Clinical Trials Unit with 24/7 telephone back-up, ensuring concealment of group assignment.”

MethodsFind in source

“Treatment assignment was blinded from the clinicians, the infant’s family and individuals who assessed outcomes.”

MethodsFind in source

“A sample size of 730 infants would be required to detect a clinically important absolute risk reduction of 12% with 90% power and a type I error of 5% from a control group event rate of 60% to a treatment group event rate of 48%, assuming 1% of infants were lost to follow-up.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Treatment assignment was blinded from the clinicians, the infant’s family and individuals who assessed outcomes.”

MethodsFind in source

Statistical analysisFind in source

The study reports sex, gestational age, birth weight, and maternal demographics in baseline characteristics. Since both sexes are enrolled, sex justification is not applicable. Age and health status are captured via gestational age and postnatal age. Species/strain and housing conditions are not applicable for a human trial.

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 including sex, gestational age, birth weight, and demographics are reported.

Evidence

paraphrase[Table 1]

“Sex — no. (%) | Male | 180 (55.6) | 175 (54.3)”

“Gestational age— weeks | 26.1±1.5 | 26.1±1.6”

Table 1Find in source

paraphrase[Table 1]

“Mother’s ethnicity— no. (%) | White | 223 (74.6) | 223 (73.6)”

PASSReviewer 2· 90% conf

Biological variables including sex, gestational age, birth weight, and demographics are reported adequately.

Evidence

“Male | 180 (55.6) | 175 (54.3)”

Table 1Find in source

“Gestational age— weeks | 26.1±1.5 | 26.1±1.6”

Table 1Find in source

paraphrase[Table 1]

“Mother’s ethnicity— no. (%) | White | 223 (74.6) | 223 (73.6)”

The paper states that written informed consent was obtained from parents. Although the specific ethics committee name is not mentioned in the text, the trial was conducted in the UK with a published protocol and funded by NIHR, implying ethical approval. The trial is registered with ISRCTN. Regulatory compliance is implied by adherence to Good Manufacturing Practice and the Declaration of Helsinki (not explicitly stated but standard).

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementINADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethical approval and informed consent are adequately reported.

Evidence

“After written informed consent was obtained from parents, infants born between 23 weeks+0 days to 28 weeks+6 days’ gestation, less than 72 hours old and confirmed by echocardiography to have a large PDA, were considered eligible.”

MethodsFind in source

“Baby-OSCAR ISRCTN Registry number, ISRCTN84264977”

AbstractFind in source

“A multicenter, randomized, double-blind, placebo-controlled trial was conducted in 32 neonatal intensive care units in the United Kingdom following a published protocol (available online with the full text of this article at NEJM.org).”

MethodsFind in source

PASSReviewer 2· 90% conf

Ethical approval and informed consent are adequately reported.

Evidence

MethodsFind in source

“(Funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme; Baby-OSCAR ISRCTN Registry number, ISRCTN84264977)”

AbstractFind in source

The trial intervention is identified as ibuprofen sodium with dosing regimen, and placebo is described as 0.9% sodium chloride. Statistical software (Stata/SE version 15) is identified. No other biological or chemical resources are used, so other sub-criteria are not applicable.

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· 85% conf

The investigational product (ibuprofen) and placebo are adequately identified, and statistical software is specified.

Evidence

“Ibuprofen was administered parenterally as loading dose of 10 mg per kilogram followed by two doses of 5 mg per kilogram at least 24 hours apart.”

MethodsFind in source

“The statistical software Stata/SE version 15 was used for all analyses.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (ibuprofen) and placebo are adequately identified, and statistical software is named.

Evidence

“Ibuprofen was administered parenterally as loading dose of 10 mg per kilogram followed by two doses of 5 mg per kilogram at least 24 hours apart.”

MethodsFind in source

“The matched placebo was supplied as a clear sterile solution of 0.9% sodium chloride.”

MethodsFind in source

“The statistical software Stata/SE version 15 was used for all analyses.”

Statistical analysisFind in source

The primary analysis uses mixed effects Poisson regression with robust variance, adjusted for minimization factors. Exact p-values are reported for the primary outcome (p=0.10). Effect sizes are reported with 95% CIs. Software is identified. Data presentation includes per-group n and percentages. Model assumptions were checked. The paper acknowledges no multiplicity adjustment for secondary 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 confidence intervals for primary outcomes.

Evidence

“Binary outcomes were analyzed using mixed effects Poisson regression with a robust variance estimator with risk ratios and 95% confidence intervals presented.”

Statistical analysisFind in source

“adjusted risk ratio [aRR], 1.09; 95% CI, 0.98 to 1.20; p=0.10”

ResultsFind in source

paraphrase[Methods, Statistical Analysis]

“Model diagnostics were checked and satisfied.”

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals.

Evidence

“Binary outcomes were analyzed using mixed effects Poisson regression with a robust variance estimator with risk ratios and 95% confidence intervals presented.”

Statistical analysisFind in source

“adjusted risk ratio [aRR], 1.09; 95% CI, 0.98 to 1.20; p=0.10”

ResultsFind in source

paraphrase[Methods, Statistical Analysis]

“Model diagnostics were checked and satisfied.”

The paper does not include a data availability statement. It mentions supplementary material available online, but no repository or data access procedure is described. Since this is a clinical trial, a data availability statement is expected. The lack of a statement is a reporting gap.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Data availability is not explicitly stated; the paper mentions supplementary material but no data repository or access mechanism.

Evidence

absence[Entire paper]

No data availability statement is present.

WARNReviewer 2· 80% conf

Data availability is not explicitly stated, but the trial is registered and protocol is available.

Evidence

absence[Entire paper]

No data availability statement is present.

“following a published protocol (available online with the full text of this article at NEJM.org)”

MethodsFind in source

The trial is registered with ISRCTN. Methods are detailed enough for replication. Limitations are explicitly discussed, including open-label treatment and under-recruitment. Conclusions are proportional to the results, noting no improvement in the primary outcome. Funding and COI are disclosed.

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.

Evidence

“Baby-OSCAR ISRCTN Registry number, ISRCTN84264977”

AbstractFind in source

“Our study has limitations. Despite adopting strict criteria to restrict its use, 29.8% of babies in the placebo arm received open-label medical therapy, the likely impact of which would have been to increase the PDA closure rate in this group and make it more difficult to demonstrate between-group differences in clinical outcomes.”

Discussion ¶7Find in source

“This study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (11/92/15).”

FundingFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are complete, limitations are discussed, and conclusions are proportional.

Evidence

“Baby-OSCAR ISRCTN Registry number, ISRCTN84264977”

AbstractFind in source

Discussion ¶5Find in source

“This study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (11/92/15).”

FundingFind in source

Registered (1 ID: ISRCTN). No reporting guideline cited.

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 29 references by DOI: 29 verified.

Copyediting

2 minor

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

No major wording or formatting errors. 2 minor suggestions below.

2 copyedit issues flagged: mostly typo, consistency.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and methodologically sound, but readers should weigh the absence of a data availability statement and the lack of explicit ethics committee details. These are reporting gaps that could warrant a correction or clarification from the authors, but they do not undermine the validity of the findings.

1.
HIGHdata code
Add a data availability statement to the manuscript (e.g., in the Methods or a dedicated section) specifying how de-identified data can be accessed, such as through a data access committee or a public repository.
The absence of a data availability statement is a reporting gap that undermines transparency and reproducibility for a clinical trial.
2.
HIGHethics
In the Methods section, explicitly name the ethics committee that approved the trial and provide the approval number.
The current paper implies ethical approval but does not name the committee, which is a reporting gap that should be corrected for full transparency.
3.
MEDIUMreporting
Add an explicit statement of adherence to CONSORT reporting guidelines in the Methods or Acknowledgments.
Explicitly stating CONSORT adherence enhances transparency and is expected for a randomized trial.
4.
MEDIUMethics
State compliance with the Declaration of Helsinki or other ethical standards explicitly in the Methods.
Explicit ethical standards compliance is a standard expectation for human research and is currently only implied.
5.
MEDIUMdata code
Provide a link to the full statistical analysis plan or protocol in the data availability statement or as a supplementary file.
Making the analysis plan accessible supports reproducibility and allows readers to verify pre-specified analyses.
6.
LOWdata code
Consider depositing the statistical analysis code in a public repository to enhance reproducibility.
Sharing analysis code is a best practice that facilitates independent verification of results.
7.
LOWcopyedit
Fix minor formatting inconsistencies in the Abstract (e.g., consistent use of brackets and spacing in 'adjusted risk ratio [aRR]').
Minor formatting issues can be polished for a cleaner presentation.
8.
LOWcopyedit
Ensure consistent em-dash spacing in Table 1 (e.g., 'Mother’s ethnicity— no. (%)').
Consistent formatting improves readability and professionalism.

Full text (30,597 chars)Analyzed: Aug 16, 2026

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Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.

Gupta S, Subhedar NV, Bell JL, Field D, Bowler U, Hutchison E, Johnson S, Kelsall W, Pepperell J, Roberts T, Sinha S, Stanbury K, Wyllie J, Hardy P, Juszczak E, Baby-OSCAR Collaborative Group

Read full text (PMC)

DOI

10.1056/NEJMoa2305582

Share this Kaimen Rigor review

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Record fingerprint

f3cd93e7207612e8a04d97d5f6dbebe706ec743880e5bbf07ff5ca50c38d6061

Verify via API

Issued Aug 16, 2026Engine 7.39.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

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: 8 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.
No data or code availability links were detected to verify.

Findings by category

01ArithmeticNone found 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit2 minor suggestions

Numerical inconsistencies

None found

Checked — nothing surfaced.

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.

Overstated conclusions

None found

Checked — nothing surfaced.

6 major claims checked against the paper's own evidence: all adequately supported.

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 study clearly establishes the scientific premise with prior work and a logical rationale for the hypothesis.

Evidence

Introduction ¶1Find in source

Introduction ¶4Find in source

“However, utilizing a prophylactic approach, most infants will receive treatment unnecessarily since PDAs can close spontaneously.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the hypothesis.

Evidence

Introduction ¶2Find in source

IntroductionFind in source

“However, utilizing a prophylactic approach, most infants will receive treatment unnecessarily since PDAs can close spontaneously.”

Introduction ¶2Find 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 proper randomization, blinding, and pre-specified analysis, though the sample size was not met.

Evidence

MethodsFind in source

“Treatment assignment was blinded from the clinicians, the infant’s family and individuals who assessed outcomes.”

MethodsFind in source

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Treatment assignment was blinded from the clinicians, the infant’s family and individuals who assessed outcomes.”

MethodsFind in source

Statistical analysisFind 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 including sex, gestational age, birth weight, and demographics are reported.

Evidence

paraphrase[Table 1]

“Sex — no. (%) | Male | 180 (55.6) | 175 (54.3)”

“Gestational age— weeks | 26.1±1.5 | 26.1±1.6”

Table 1Find in source

paraphrase[Table 1]

“Mother’s ethnicity— no. (%) | White | 223 (74.6) | 223 (73.6)”

PASSReviewer 2· 90% conf

Biological variables including sex, gestational age, birth weight, and demographics are reported adequately.

Evidence

“Male | 180 (55.6) | 175 (54.3)”

Table 1Find in source

“Gestational age— weeks | 26.1±1.5 | 26.1±1.6”

Table 1Find in source

paraphrase[Table 1]

“Mother’s ethnicity— no. (%) | White | 223 (74.6) | 223 (73.6)”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementINADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethical approval and informed consent are adequately reported.

Evidence

MethodsFind in source

“Baby-OSCAR ISRCTN Registry number, ISRCTN84264977”

AbstractFind in source

MethodsFind in source

PASSReviewer 2· 90% conf

Ethical approval and informed consent are adequately reported.

Evidence

MethodsFind in source

“(Funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme; Baby-OSCAR ISRCTN Registry number, ISRCTN84264977)”

AbstractFind 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· 85% conf

The investigational product (ibuprofen) and placebo are adequately identified, and statistical software is specified.

Evidence

“Ibuprofen was administered parenterally as loading dose of 10 mg per kilogram followed by two doses of 5 mg per kilogram at least 24 hours apart.”

MethodsFind in source

“The statistical software Stata/SE version 15 was used for all analyses.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (ibuprofen) and placebo are adequately identified, and statistical software is named.

Evidence

“Ibuprofen was administered parenterally as loading dose of 10 mg per kilogram followed by two doses of 5 mg per kilogram at least 24 hours apart.”

MethodsFind in source

“The matched placebo was supplied as a clear sterile solution of 0.9% sodium chloride.”

MethodsFind in source

“The statistical software Stata/SE version 15 was used for all analyses.”

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 confidence intervals for primary outcomes.

Evidence

“Binary outcomes were analyzed using mixed effects Poisson regression with a robust variance estimator with risk ratios and 95% confidence intervals presented.”

Statistical analysisFind in source

“adjusted risk ratio [aRR], 1.09; 95% CI, 0.98 to 1.20; p=0.10”

ResultsFind in source

paraphrase[Methods, Statistical Analysis]

“Model diagnostics were checked and satisfied.”

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals.

Evidence

“Binary outcomes were analyzed using mixed effects Poisson regression with a robust variance estimator with risk ratios and 95% confidence intervals presented.”

Statistical analysisFind in source

“adjusted risk ratio [aRR], 1.09; 95% CI, 0.98 to 1.20; p=0.10”

ResultsFind in source

paraphrase[Methods, Statistical Analysis]

“Model diagnostics were checked and satisfied.”

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Data availability is not explicitly stated; the paper mentions supplementary material but no data repository or access mechanism.

Evidence

absence[Entire paper]

No data availability statement is present.

WARNReviewer 2· 80% conf

Data availability is not explicitly stated, but the trial is registered and protocol is available.

Evidence

absence[Entire paper]

No data availability statement is present.

“following a published protocol (available online with the full text of this article at NEJM.org)”

MethodsFind 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.

Evidence

“Baby-OSCAR ISRCTN Registry number, ISRCTN84264977”

AbstractFind in source

Discussion ¶7Find in source

“This study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (11/92/15).”

FundingFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are complete, limitations are discussed, and conclusions are proportional.

Evidence

“Baby-OSCAR ISRCTN Registry number, ISRCTN84264977”

AbstractFind in source

Discussion ¶5Find in source

“This study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (11/92/15).”

FundingFind in source

Registered (1 ID: ISRCTN). No reporting guideline cited.

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 29 references by DOI: 29 verified.

Copyediting

2 minor

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

No major wording or formatting errors. 2 minor suggestions below.

2 copyedit issues flagged: mostly typo, consistency.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Add a data availability statement to the manuscript (e.g., in the Methods or a dedicated section) specifying how de-identified data can be accessed, such as through a data access committee or a public repository.
The absence of a data availability statement is a reporting gap that undermines transparency and reproducibility for a clinical trial.
2.
HIGHethics
In the Methods section, explicitly name the ethics committee that approved the trial and provide the approval number.
The current paper implies ethical approval but does not name the committee, which is a reporting gap that should be corrected for full transparency.
3.
MEDIUMreporting
Add an explicit statement of adherence to CONSORT reporting guidelines in the Methods or Acknowledgments.
Explicitly stating CONSORT adherence enhances transparency and is expected for a randomized trial.
4.
MEDIUMethics
State compliance with the Declaration of Helsinki or other ethical standards explicitly in the Methods.
Explicit ethical standards compliance is a standard expectation for human research and is currently only implied.
5.
MEDIUMdata code
Provide a link to the full statistical analysis plan or protocol in the data availability statement or as a supplementary file.
Making the analysis plan accessible supports reproducibility and allows readers to verify pre-specified analyses.
6.
LOWdata code
Consider depositing the statistical analysis code in a public repository to enhance reproducibility.
Sharing analysis code is a best practice that facilitates independent verification of results.
7.
LOWcopyedit
Fix minor formatting inconsistencies in the Abstract (e.g., consistent use of brackets and spacing in 'adjusted risk ratio [aRR]').
Minor formatting issues can be polished for a cleaner presentation.
8.
LOWcopyedit
Ensure consistent em-dash spacing in Table 1 (e.g., 'Mother’s ethnicity— no. (%)').
Consistent formatting improves readability and professionalism.

Full text (30,597 chars)Analyzed: Aug 16, 2026