Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.

Name: Kaimen Rigor review — Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.
Item: Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.
Rating: 100
Author: Alpha1

Li Y, Zhu X, Li LJ, Chen L, Yang Q, Xu L, Liang W, Lin X, Li C, Xue J, Liu L, Pan X, Ju R, Peng X, Tang W, Shi Y, NHFOV study group

Paper source

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Kaimen Rigor review — 5★ (Exemplary), 0 critical, 2 high issues for “Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.”

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Alpha1 Editorial

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

Read alongside

Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.

Li Y, Zhu X, Li LJ, Chen L, Yang Q, Xu L, Liang W, Lin X, Li C, Xue J, Liu L, Pan X, Ju R, Peng X, Tang W, Shi Y, NHFOV study group

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DOI

10.1136/bmj-2025-085569

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.

Li Y, Zhu X, Li LJ, Chen L, Yang Q, Xu L, Liang W, Lin X, Li C, Xue J, Liu L, Pan X, Ju R, Peng X, Tang W, Shi Y, NHFOV study group

Paper source

Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.

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

5 / 5

Exemplary — no material problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.

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

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit6 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 well-reported multicentre RCT comparing NHFOV with NCPAP in extremely preterm infants. The paper demonstrates strong methodological rigor across all eight dimensions, with minor reporting gaps in outlier handling and statistical assumption verification.

Both reviewers classified the study as interventional, which is adopted. The evaluation covers all eight dimensions; no dimensions were excluded as not applicable. The reviewers converged closely, with minor disagreements on outlier handling and demographics reporting, which were resolved by weighing the evidence.

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

1 finding · worst low

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 only partially backed by the presented evidenceAssessed

7 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

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

None found

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.

Checked — nothing surfaced.

Eight Dimensions8 pass

The paper cites prior work on NCPAP failure rates and NHFOV's physiological advantages, and notes inconsistent findings from previous RCTs. The hypothesis follows logically from the cited evidence. Limitations of prior research (e.g., inconsistent findings, underpowered studies) are acknowledged and addressed by the trial's design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear rationale for comparing NHFOV with NCPAP, citing prior research and identifying the gap in evidence.

Evidence

“However, cumulative evidence has suggested that up to 40% of extremely preterm infants are prone to a high risk of NCPAP failure because of chest wall collapse and poor diaphragmatic strength.”

Introduction ¶1Find in source

“We hypothesised that NHFOV would be more effective than NCPAP in reducing treatment failure within 72 hours after birth in a homogeneous population of Chinese extremely preterm infants.”

IntroductionFind in source

“Several randomised controlled trials comparing NHFOV and NCPAP have reported inconsistent findings about their effectiveness in managing respiratory distress syndrome.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The introduction establishes the clinical problem, cites prior research including inconsistent RCTs, and provides a clear rationale and hypothesis.

Evidence

“Several randomised controlled trials comparing NHFOV and NCPAP have reported inconsistent findings about their effectiveness in managing respiratory distress syndrome.”

Introduction ¶1Find in source

“We hypothesised that NHFOV would be more effective than NCPAP in reducing treatment failure within 72 hours after birth in a homogeneous population of Chinese extremely preterm infants.”

IntroductionFind in source

Randomization used a computer-generated sequence with central allocation concealment and stratification by centre. Outcome assessors were masked, though caregivers were not due to the nature of the intervention. A power analysis was performed with a stated effect size, alpha, and power. Inclusion/exclusion criteria were pre-specified. The analysis was intention-to-treat. Outlier handling is not explicitly described, but the analysis population is defined.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial uses appropriate randomization, blinding of outcome assessors, and a pre-specified sample size calculation, with clear inclusion/exclusion criteria.

Evidence

“Simple randomisation was performed using a computer generated random number sequence, which was securely posted on a dedicated, password protected website accessible 24/7.”

MethodsFind in source

“However, outcome assessors were masked to the treatment allocation to minimise ascertainment bias.”

MethodsFind in source

“With a significance level (α) of 0.05 and 90% power, a sample size of 170 newborns per group was required, leading to a total enrolment target of at least 340.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial uses appropriate randomization, allocation concealment, outcome assessor blinding, and a pre-specified sample size calculation.

Evidence

“Simple randomisation was performed using a computer generated random number sequence, which was securely posted on a dedicated, password protected website accessible 24/7.”

MethodsFind in source

“However, outcome assessors were masked to the treatment allocation to minimise ascertainment bias.”

MethodsFind in source

“With a significance level (α) of 0.05 and 90% power, a sample size of 170 newborns per group was required, leading to a total enrolment target of at least 340.”

Statistical analysisFind in source

The paper reports sex, gestational age, birth weight, and multiple other baseline characteristics. Since both sexes are enrolled, sex justification is not applicable. Demographics are reported in detail. 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 such as gestational age, birth weight, sex, and other baseline characteristics are reported in Table 1.

Evidence

“Female | 74 (43.5) | 68 (39.5)”

Table 1Find in source

“Gestational age (weeks), median (IQR) | 27.0 (26.0-28.0) | 27.0 (26.0-28.0)”

Table 1Find in source

PASSReviewer 2· 90% conf

Key biological variables (sex, gestational age, birth weight) are reported and balanced between groups.

Evidence

“Female | 74 (43.5) | 68 (39.5)”

Table 1Find in source

“Gestational age (weeks), median (IQR) | 27.0 (26.0-28.0) | 27.0 (26.0-28.0)”

Table 1Find in source

The paper states approval by the Ethics Committee of the Children's Hospital of Chongqing Medical University (No 2019.161) and local IRBs. Written informed consent was obtained. Compliance with CONSORT and relevant regulations is mentioned.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study reports ethics approval from a named committee and informed consent from parents/guardians.

Evidence

“The study was approved by the ethics committee of the Children's Hospital of Chongqing Medical University (No 2019.161)”

MethodsFind in source

“Informed consent was obtained from parents or guardians antenatally or upon admission to the neonatal intensive care unit”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval from a named committee and informed consent are documented.

Evidence

“The study was approved by the ethics committee of the Children's Hospital of Chongqing Medical University (No 2019.161)”

MethodsFind in source

“Informed consent was obtained from parents or guardians antenatally or upon admission to the neonatal intensive care unit”

MethodsFind in source

The trial uses specific devices (Comen NV8, Mindray NB350, Fabian-III, SLE 5000, Leoni+) and drugs (caffeine citrate, Curosurf) with manufacturers and doses. Software (R version 4.4.2) is identified. Antibodies, cell lines, and mycoplasma testing 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· 90% conf

The investigational products (NCPAP and NHFOV devices) and drugs (caffeine, surfactant) are identified with manufacturer and dosing details.

Evidence

“Continuous flow devices (Comen NV8, China; Mindray NB350, China; supplementary eTable 2) were used to provide NCPAP.”

MethodsFind in source

“Surfactant treatment (Curosurf, Chiesi Pharmaceuticals) was administered at a dose of 200 mg/kg”

MethodsFind in source

“All statistical analyses were conducted in R software (version 4.4.2).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Investigational products and devices are identified with manufacturer and dosing details.

Evidence

“Continuous flow devices (Comen NV8, China; Mindray NB350, China; supplementary eTable 2) were used to provide NCPAP.”

MethodsFind in source

“Surfactant treatment (Curosurf, Chiesi Pharmaceuticals) was administered at a dose of 200 mg/kg”

MethodsFind in source

“All statistical analyses were conducted in R software (version 4.4.2).”

Statistical analysisFind in source

The paper names tests (Student's t, Mann-Whitney U, χ²) and reports risk differences with 95% CIs. Exact p-values are given for primary and secondary outcomes. Data presentation includes per-group n and percentages. 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 tests are named, effect sizes with confidence intervals are reported, and the software is identified. Exact p-values are provided for primary outcomes.

Evidence

“Comparisons were performed using Student’s t test for parametric continuous variables, Mann-Whitney U test for non-parametric continuous variables, and χ 2 test for dichotomous variables, respectively.”

Statistical analysisFind in source

“risk difference −12.0 percentage points, 95% confidence interval −20.7 to −3.4; P=0.007”

ResultsFind in source

“risk difference −12.0 percentage points, 95% confidence interval −20.7 to −3.4”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical tests are named, effect sizes with CIs are reported, and software is identified. Exact p-values are provided.

Evidence

Statistical analysisFind in source

“Treatment failure within 72 hours after birth occurred in 27 of 170 infants (15.9%) in the NHFOV group and 48 of 172 (27.9%) in the NCPAP group (risk difference −12.0 percentage points, 95% confidence interval −20.7 to −3.4; P=0.007; ).”

ResultsFind in source

The data availability statement provides a concrete route: a Mendeley Data repository with a DOI. Code is stated to be in supplemental files. Repository deposit and accession numbers are satisfied by the Mendeley DOI.

Sub-criteria

code sharingADEQUATE

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data are openly available in a repository with a DOI, and code is available in supplemental files.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at https://data.mendeley.com/datasets/66gc4zb37c/1 or Zhu, Xingwang (2025) “NHFOV as Primary Support in Very Preterm Infants With RDS,” Mendeley Data, V1, doi: 10.17632/66gc4zb37c.1”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code are openly available with a DOI and a public repository link.

Evidence

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

Data availabilityFind in source

Trial registration number is provided. CONSORT compliance is stated. Limitations are discussed in detail. Conclusions are proportional. Funding sources and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

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, follows CONSORT, reports all outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov NCT05141435”

AbstractFind in source

“The trial was conducted in compliance with CONSORT (consolidated standards of reporting trials) guidelines.”

MethodsFind in source

“Clinician masking was unfeasible owing to the inherently distinct interventions, which may have introduced selection, performance, or detection bias.”

LimitationsFind in source

PASSReviewer 2· 95% conf

The trial is registered, CONSORT is followed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration ClinicalTrials.gov NCT05141435”

AbstractFind in source

“The trial was conducted in compliance with CONSORT (consolidated standards of reporting trials) guidelines.”

MethodsFind in source

“Clinician masking was unfeasible owing to the inherently distinct interventions, which may have introduced selection, performance, or detection bias.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

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: 36 verified — 1 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

6 minor

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

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published paper is robust and well-reported. An informed reader should note the minor gaps in explicit outlier handling and statistical assumption verification, but these do not undermine the overall validity. No erratum or correction is warranted based on this audit.

1.
HIGHreporting
Add an explicit statement in the Methods (Statistical analysis) on how outliers were handled, e.g., whether any data points were excluded and on what basis.
Both reviewers noted that outlier handling is not explicitly described, which is a standard reporting expectation for clinical trials.
2.
HIGHstatistics
Clarify in the Methods (Statistical analysis) how normality and equal variance assumptions were verified for parametric tests, or state that non-parametric tests were used due to non-normality.
Reviewer 2 flagged assumptions_verified as inadequate; explicit verification strengthens statistical rigor.
3.
MEDIUMdata code
Deposit the analysis code in a public repository (e.g., GitHub, Zenodo) with a DOI, rather than only in supplemental files.
Both reviewers suggested this to enhance long-term reproducibility and discoverability.
4.
MEDIUMreporting
Provide a link to the trial protocol publication or registration record for full methodological details.
Reviewer 2 suggested this to allow readers to access the pre-specified analysis plan.
5.
MEDIUMreporting
Clarify the exact role of the local institutional review boards in the ethics approval statement, as only the central committee's approval number is given.
Reviewer 1 noted this as a minor reporting gap for transparency.
6.
MEDIUMreporting
Consider reporting additional demographic details such as race/ethnicity if available, to enhance generalizability.
Reviewer 2 suggested this as a potential improvement for demographic reporting.
7.
LOWcopyedit
Fix typo in Author affiliations: change 'Resrach' to 'Research'.
Copyedit pass flagged this minor typo.
8.
LOWcopyedit
Fix typo in Author affiliations: change 'Yunan' to 'Yunnan'.
Copyedit pass flagged this misspelling of the province name.
9.
LOWcopyedit
Add a space before parenthesis in Table 3: change '80/172(46.5)' to '80/172 (46.5)'.
Copyedit pass flagged this consistency issue.
10.
LOWcopyedit
Fix hyphenation in Methods (Statistical analysis): change 'two tailed' to 'two-tailed'.
Copyedit pass flagged this clarity issue.
11.
LOWcopyedit
Remove stray backtick in Abstract: change '27 of` 170' to '27 of 170'.
Copyedit pass flagged this typo.
12.
LOWcopyedit
Clarify in Methods (Statistical analysis) when mean difference vs. Hodges-Lehmann median difference is used for continuous outcomes.
Copyedit pass flagged this ambiguity in reporting method selection.

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Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.

Li Y, Zhu X, Li LJ, Chen L, Yang Q, Xu L, Liang W, Lin X, Li C, Xue J, Liu L, Pan X, Ju R, Peng X, Tang W, Shi Y, NHFOV study group

Read full text (PMC)

DOI

10.1136/bmj-2025-085569

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Record fingerprint

8d269bc3ee32ca69db73c4f99db885dd1baa32d4e483373ec641d8ca9e982795

Verify via API

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

5 / 5

Exemplary — no material problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.

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

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit6 minor suggestions

Numerical inconsistencies

None found

Checked — nothing surfaced.

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

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

7 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear rationale for comparing NHFOV with NCPAP, citing prior research and identifying the gap in evidence.

Evidence

“However, cumulative evidence has suggested that up to 40% of extremely preterm infants are prone to a high risk of NCPAP failure because of chest wall collapse and poor diaphragmatic strength.”

Introduction ¶1Find in source

“We hypothesised that NHFOV would be more effective than NCPAP in reducing treatment failure within 72 hours after birth in a homogeneous population of Chinese extremely preterm infants.”

IntroductionFind in source

“Several randomised controlled trials comparing NHFOV and NCPAP have reported inconsistent findings about their effectiveness in managing respiratory distress syndrome.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The introduction establishes the clinical problem, cites prior research including inconsistent RCTs, and provides a clear rationale and hypothesis.

Evidence

“Several randomised controlled trials comparing NHFOV and NCPAP have reported inconsistent findings about their effectiveness in managing respiratory distress syndrome.”

Introduction ¶1Find in source

“We hypothesised that NHFOV would be more effective than NCPAP in reducing treatment failure within 72 hours after birth in a homogeneous population of Chinese extremely preterm infants.”

IntroductionFind in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial uses appropriate randomization, blinding of outcome assessors, and a pre-specified sample size calculation, with clear inclusion/exclusion criteria.

Evidence

“Simple randomisation was performed using a computer generated random number sequence, which was securely posted on a dedicated, password protected website accessible 24/7.”

MethodsFind in source

“However, outcome assessors were masked to the treatment allocation to minimise ascertainment bias.”

MethodsFind in source

“With a significance level (α) of 0.05 and 90% power, a sample size of 170 newborns per group was required, leading to a total enrolment target of at least 340.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial uses appropriate randomization, allocation concealment, outcome assessor blinding, and a pre-specified sample size calculation.

Evidence

“Simple randomisation was performed using a computer generated random number sequence, which was securely posted on a dedicated, password protected website accessible 24/7.”

MethodsFind in source

“However, outcome assessors were masked to the treatment allocation to minimise ascertainment bias.”

MethodsFind in source

“With a significance level (α) of 0.05 and 90% power, a sample size of 170 newborns per group was required, leading to a total enrolment target of at least 340.”

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 such as gestational age, birth weight, sex, and other baseline characteristics are reported in Table 1.

Evidence

“Female | 74 (43.5) | 68 (39.5)”

Table 1Find in source

“Gestational age (weeks), median (IQR) | 27.0 (26.0-28.0) | 27.0 (26.0-28.0)”

Table 1Find in source

PASSReviewer 2· 90% conf

Key biological variables (sex, gestational age, birth weight) are reported and balanced between groups.

Evidence

“Female | 74 (43.5) | 68 (39.5)”

Table 1Find in source

“Gestational age (weeks), median (IQR) | 27.0 (26.0-28.0) | 27.0 (26.0-28.0)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study reports ethics approval from a named committee and informed consent from parents/guardians.

Evidence

“The study was approved by the ethics committee of the Children's Hospital of Chongqing Medical University (No 2019.161)”

MethodsFind in source

“Informed consent was obtained from parents or guardians antenatally or upon admission to the neonatal intensive care unit”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval from a named committee and informed consent are documented.

Evidence

“The study was approved by the ethics committee of the Children's Hospital of Chongqing Medical University (No 2019.161)”

MethodsFind in source

“Informed consent was obtained from parents or guardians antenatally or upon admission to the neonatal intensive care unit”

MethodsFind 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 (NCPAP and NHFOV devices) and drugs (caffeine, surfactant) are identified with manufacturer and dosing details.

Evidence

“Continuous flow devices (Comen NV8, China; Mindray NB350, China; supplementary eTable 2) were used to provide NCPAP.”

MethodsFind in source

“Surfactant treatment (Curosurf, Chiesi Pharmaceuticals) was administered at a dose of 200 mg/kg”

MethodsFind in source

“All statistical analyses were conducted in R software (version 4.4.2).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Investigational products and devices are identified with manufacturer and dosing details.

Evidence

“Continuous flow devices (Comen NV8, China; Mindray NB350, China; supplementary eTable 2) were used to provide NCPAP.”

MethodsFind in source

“Surfactant treatment (Curosurf, Chiesi Pharmaceuticals) was administered at a dose of 200 mg/kg”

MethodsFind in source

“All statistical analyses were conducted in R software (version 4.4.2).”

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 tests are named, effect sizes with confidence intervals are reported, and the software is identified. Exact p-values are provided for primary outcomes.

Evidence

Statistical analysisFind in source

“risk difference −12.0 percentage points, 95% confidence interval −20.7 to −3.4; P=0.007”

ResultsFind in source

“risk difference −12.0 percentage points, 95% confidence interval −20.7 to −3.4”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical tests are named, effect sizes with CIs are reported, and software is identified. Exact p-values are provided.

Evidence

Statistical analysisFind in source

ResultsFind in source

Sub-criteria

code sharingADEQUATE

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data are openly available in a repository with a DOI, and code is available in supplemental files.

Evidence

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code are openly available with a DOI and a public repository link.

Evidence

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

Data availabilityFind in source

Trial registration number is provided. CONSORT compliance is stated. Limitations are discussed in detail. Conclusions are proportional. Funding sources and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

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, follows CONSORT, reports all outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov NCT05141435”

AbstractFind in source

“The trial was conducted in compliance with CONSORT (consolidated standards of reporting trials) guidelines.”

MethodsFind in source

“Clinician masking was unfeasible owing to the inherently distinct interventions, which may have introduced selection, performance, or detection bias.”

LimitationsFind in source

PASSReviewer 2· 95% conf

The trial is registered, CONSORT is followed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration ClinicalTrials.gov NCT05141435”

AbstractFind in source

“The trial was conducted in compliance with CONSORT (consolidated standards of reporting trials) guidelines.”

MethodsFind in source

“Clinician masking was unfeasible owing to the inherently distinct interventions, which may have introduced selection, performance, or detection bias.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

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: 36 verified — 1 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

6 minor

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

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHreporting
Add an explicit statement in the Methods (Statistical analysis) on how outliers were handled, e.g., whether any data points were excluded and on what basis.
Both reviewers noted that outlier handling is not explicitly described, which is a standard reporting expectation for clinical trials.
2.
HIGHstatistics
Clarify in the Methods (Statistical analysis) how normality and equal variance assumptions were verified for parametric tests, or state that non-parametric tests were used due to non-normality.
Reviewer 2 flagged assumptions_verified as inadequate; explicit verification strengthens statistical rigor.
3.
MEDIUMdata code
Deposit the analysis code in a public repository (e.g., GitHub, Zenodo) with a DOI, rather than only in supplemental files.
Both reviewers suggested this to enhance long-term reproducibility and discoverability.
4.
MEDIUMreporting
Provide a link to the trial protocol publication or registration record for full methodological details.
Reviewer 2 suggested this to allow readers to access the pre-specified analysis plan.
5.
MEDIUMreporting
Clarify the exact role of the local institutional review boards in the ethics approval statement, as only the central committee's approval number is given.
Reviewer 1 noted this as a minor reporting gap for transparency.
6.
MEDIUMreporting
Consider reporting additional demographic details such as race/ethnicity if available, to enhance generalizability.
Reviewer 2 suggested this as a potential improvement for demographic reporting.
7.
LOWcopyedit
Fix typo in Author affiliations: change 'Resrach' to 'Research'.
Copyedit pass flagged this minor typo.
8.
LOWcopyedit
Fix typo in Author affiliations: change 'Yunan' to 'Yunnan'.
Copyedit pass flagged this misspelling of the province name.
9.
LOWcopyedit
Add a space before parenthesis in Table 3: change '80/172(46.5)' to '80/172 (46.5)'.
Copyedit pass flagged this consistency issue.
10.
LOWcopyedit
Fix hyphenation in Methods (Statistical analysis): change 'two tailed' to 'two-tailed'.
Copyedit pass flagged this clarity issue.
11.
LOWcopyedit
Remove stray backtick in Abstract: change '27 of` 170' to '27 of 170'.
Copyedit pass flagged this typo.
12.
LOWcopyedit
Clarify in Methods (Statistical analysis) when mean difference vs. Hodges-Lehmann median difference is used for continuous outcomes.
Copyedit pass flagged this ambiguity in reporting method selection.

Full text (41,073 chars)Analyzed: Aug 15, 2026