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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: 59
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.

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Kaimen Rigor review — 3★ (Adequate), 0 critical, 5 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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This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

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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.

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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

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ReportingEthical approvals partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.29.0Source: full text

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 06Copyedit19 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, well-reported multicentre RCT comparing NHFOV vs. NCPAP in extremely preterm infants. The study demonstrates strong methodological rigor in design, statistical analysis, and reporting transparency. Two minor reporting gaps—lack of a named ethics framework and analysis code only in supplemental files—result in 'warn' ratings for ethical_approvals and data_code_availability, but these do not undermine the paper's core validity.

This is a post-publication audit of an already published RCT. The evaluation covered all eight dimensions of scientific rigor. The study is a human interventional trial, so criteria such as animal housing, cell line authentication, and independent replication were scored as not applicable. The three independent reviewer runs converged on most dimensions; the main disagreements were on ethical approvals and data code availability, which were resolved by applying the scoring rules to the checklist sub-criteria.

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 11 tests: 11 consistent, 0 inconsistent; 11 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

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

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

Data authenticity concerns

1 finding · worst low

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.

Other integrity concernAssessed

3 integrity concerns flagged (0 high).

Reporting gaps

2 findings · 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
Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 2 warn

The introduction discusses the limitations of NCPAP, the potential advantages of NHFOV, and the inconsistent findings from previous trials, leading to a clear hypothesis for the current study. It explicitly states the gap in knowledge regarding NHFOV as primary respiratory support.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes its premise by citing prior work, outlining the limitations of current treatments, and providing a logical rationale for investigating NHFOV.

Evidence

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

Introduction ¶4Find in source

“NHFOV may provide dual physiological advantages over NCPAP by maintaining lung recruitment while actively clearing carbon dioxide through oscillatory gas mixing—a mechanism particularly beneficial for non-uniformly diseased lungs.”

Introduction ¶3Find in source

“However, its efficacy as primary respiratory support for respiratory distress syndrome in preterm infants remains unproven.”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

The premise is well established: prior guidelines, epidemiological context, and prior RCTs with inconsistent findings are cited, and a clear hypothesis follows.

Evidence

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

Introduction ¶4Find 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

“Importantly, our study design addressed a key historical limitation in comparing NHFOV and NCPAP: variability in applied airway pressures.”

DiscussionFind in source

PASSReviewer 3· 90% conf

The premise is well established: the introduction cites consensus guidelines, NCPAP-failure rates, mechanistic rationale for NHFOV, and prior inconsistent RCTs, and derives a clear directional hypothesis.

Evidence

“European consensus guidelines recommend nasal continuous positive airway pressure (NCPAP) as the preferred first line respiratory support strategy”

IntroductionFind in source

“However, its efficacy as primary respiratory support for respiratory distress syndrome in preterm infants remains unproven.”

IntroductionFind in source

“We hypothesised that NHFOV would be more effective than NCPAP in reducing treatment failure within 72 hours after birth”

IntroductionFind in source

The paper describes simple randomisation using a computer-generated sequence and central management for allocation concealment. Outcome assessors were masked, and a power analysis determined the sample size. Inclusion and exclusion criteria were clearly stated, and the study used appropriate controls (NCPAP group).

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study design is robust, featuring central randomisation, allocation concealment, and outcome assessor blinding. A power analysis was conducted, and clear inclusion/exclusion criteria were defined.

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.”

Methods ¶1Find in source

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

Methods ¶1Find 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 analysis ¶1Find in source

PASSReviewer 2· 85% conf

Randomization method, unit, masking, power analysis, and inclusion/exclusion criteria are all reported adequately; ITT analysis is stated.

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 3· 90% conf

Core design elements for a human RCT are adequately reported: a priori power calculation, computer-generated central randomisation with allocation concealment, pre-specified eligibility criteria, masked outcome assessment with an open-label rationale, and ITT analysis.

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

“With a significance level (α) of 0.05 and 90% power, a sample size of 170 newborns per group was required”

Statistical analysisFind in source

paraphrase[Methods, Randomisation and masking]

“Owing to the nature of the intervention with the distinct characteristics of the ventilation modalities, masking of care givers was not feasible ... However, outcome assessors were masked to the treatment allocation”

The paper provides detailed demographics for the enrolled infants in Table 1, including gestational age, birth weight, sex (female percentage), and other relevant health statuses and clinical characteristics.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study adequately reports key demographic and biological characteristics of the human participants, including gestational age, birth weight, and sex.

Evidence

paraphrase[Table 1]

“Gestational age (weeks), median (IQR) | 27.0 (26.0-28.0) | 27.0 (26.0-28.0) | Birth weight (g), median (IQR) | 990 (820-1100) | 970 (880-1090)”

“Female | 74 (43.5) | 68 (39.5)”

Table 1Find in source

paraphrase[Table 1]

“Table 1 includes information on multiple birth, premature rupture of membranes, chorioamnionitis, small for gestational age, prenatal corticosteroid prophylaxis, Caesarean delivery, delayed umbilical cord ligation, Apgar score, and various clinical scores and blood gas parameters before enrolment.”

PASSReviewer 2· 85% conf

Sex, gestational age, birth weight, and key clinical characteristics are reported in baseline tables; both sexes are enrolled so no single-sex justification is needed.

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 3· 85% conf

Sex, gestational age, birth weight, and health status are reported in baseline tables; the cohort is an all-Chinese preterm population. Race/ethnicity is not explicitly stated, a minor gap.

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

absence[Methods, Study design]

Race/ethnicity is not explicitly reported (population is Chinese by setting).

The protocol was approved by a named ethics committee with a protocol number (No 2019.161) and local IRBs, and written informed consent was obtained from parents/guardians. However, regulatory compliance is only stated vaguely as 'data were anonymised in accordance with relevant local regulations' — no recognised framework (e.g., Declaration of Helsinki, ICH-GCP) is named. Under the scoring rule, any applicable inadequate/not-reported item yields a warn.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study explicitly states ethical approval from a named committee, provides a protocol number, and confirms informed consent was obtained from parents or guardians.

Evidence

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

Methods ¶1Find in source

“Informed consent was obtained from parents or guardians antenatally or upon admission to the neonatal intensive care unit, and data were anonymised in accordance with relevant local regulations.”

Methods ¶1Find in source

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

Methods ¶1Find in source

WARNReviewer 2· 70% conf

IRB approval (named committee with protocol number) and written informed consent are clearly reported, but no named regulatory framework (e.g., Declaration of Helsinki, ICH-GCP) is cited.

Evidence

“The protocol was approved by the Ethics Committee of the Children’s Hospital of Chongqing Medical University (No 2019.161) and local institutional review boards of the participating centres.”

EthicsFind in source

“All parents or guardians provided written informed consent.”

EthicsFind in source

“data were anonymised in accordance with relevant local regulations.”

MethodsFind in source

WARNReviewer 3· 70% conf

Named ethics approval and written informed consent are clearly documented, but no recognized regulatory/research-ethics framework (e.g., Declaration of Helsinki, GCP) is named — only 'relevant local regulations' and CONSORT (a reporting guideline).

Evidence

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

MethodsFind in source

“All parents or guardians provided written informed consent.”

EthicsFind in source

“data were anonymised in accordance with relevant local regulations. The trial was conducted in compliance with CONSORT”

MethodsFind in source

The paper identifies the continuous flow devices used for NCPAP (Comen NV8, Mindray NB350) and the piston or membrane oscillators for NHFOV (Fabian-III, SLE 5000, Leoni+), along with their manufacturers. Specific medications like caffeine citrate and Curosurf are also named with their manufacturers. The statistical software and version are reported.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Key reagents and equipment, including specific ventilation devices and medications, are identified with manufacturer information. Statistical software and version are also reported.

Evidence

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

Methods ¶2Find in source

“NHFOV was delivered using piston or membrane oscillators capable of active expiration, including the Fabian-III (Acutronic, Switzerland), SLE 5000 (SLE (UK)) and Leoni+ (Löwenstein Medical, Germany; supplementary eTable 2).”

Methods ¶3Find in source

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

Statistical analysis ¶3Find in source

PASSReviewer 2· 80% conf

The investigational devices and key pharmaceuticals are identified with manufacturers, and analysis software (R 4.4.2) is named; bench-science criteria are not applicable.

Evidence

MethodsFind in source

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

Statistical analysisFind in source

PASSReviewer 3· 80% conf

The investigational devices (ventilators) and co-interventions (surfactant, caffeine) are identified with manufacturer/source and dosing, and the analysis software is versioned.

Evidence

paraphrase[Methods, Study procedure]

“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 explicitly names the statistical tests used (Student’s t test, Mann-Whitney U test, χ² test). It reports exact p-values and 95% confidence intervals for risk differences. The statistical software (R version 4.4.2) is identified. Data presentation in tables includes per-group Ns, percentages, medians with IQRs, and risk differences with 95% CIs.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedNOT REPORTED

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly names statistical tests, reports exact p-values and confidence intervals for effect sizes, and identifies the software used. Data presentation includes per-group Ns and appropriate measures of dispersion.

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 analysis ¶2Find 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; ).”

Results ¶1Find in source

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

Statistical analysis ¶3Find in source

PASSReviewer 2· 85% conf

Tests are named, exact p-values and effect sizes with 95% CIs are reported, software is identified, and all reported percentages are arithmetically consistent.

Evidence

Statistical analysisFind in source

ResultsFind in source

PASSReviewer 3· 90% conf

Tests are named, exact p-values and effect sizes with 95% CIs are reported, software is versioned, and the reported proportions are arithmetically plausible against the stated denominators.

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”

Statistical analysisFind in source

paraphrase[Results, Primary outcome]

“Female | 74 (43.5) | 68 (39.5)”

Table 1Find in source

The data availability statement names a concrete route (Mendeley Data, doi: 10.17632/66gc4zb37c.1) and the data are deposited there, so data_availability_statement and repository_deposit are adequate. accession_numbers is n/a for patient data. code_sharing is reported_but_inadequate: 'The code used to analyse the data in the paper can be found in the supplemental files' — supplemental files are not a version-controlled public repo with a persistent identifier. Two of three applicable criteria adequate → warn.

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper includes a data availability statement, provides a public repository link with a DOI for the data, and states that code is available in supplemental files.

Evidence

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

WARNReviewer 2· 80% conf

Data are deposited in Mendeley Data with a DOI, but the analysis code is only available in supplemental files rather than a version-controlled public repository with a persistent identifier.

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”

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

WARNReviewer 3· 85% conf

Data are openly deposited in Mendeley with a DOI, but the analysis code is only placed in 'supplemental files' rather than a version-controlled public repository with a permanent identifier.

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”

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

The methods section is comprehensive, detailing interventions, procedures, and outcome definitions. The trial is registered on ClinicalTrials.gov, and adherence to CONSORT guidelines is stated. Limitations are explicitly discussed, and funding sources and conflicts of interest are provided.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study provides sufficient methodological detail for replication, is registered as a clinical trial, references CONSORT guidelines, discusses limitations, and includes funding and COI statements.

Evidence

“Trial registration ClinicalTrials.gov NCT05141435 (https://clinicaltrials.gov/ct2/show/NCT05141435)”

AbstractFind in source

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

Methods ¶1Find in source

“Nevertheless, several limitations should be acknowledged. Clinician masking was unfeasible owing to the inherently distinct interventions, which may have introduced selection, performance, or detection bias.”

Limitations ¶1Find in source

“Funding: The study was partially funded by National Key Research and Development Program of China (No 2022YFC2704803); Natural Science Foundation of Chongqing (CSTB2024NSCQ-MSX0158); Hunan Provincial Clinical Research Center for Newborn Diseases of Maternal Origins (2023SK4057); the Chongqing Maternal and Child Disease Prevention and Control and Public Health Research Project (CQFYJB01008); Key Research and Development Program of Jiangxi (20243BBI91020); and Clinical Research Project for the Summit Program of Children’s Hospital of Chongqing Medical University (CHCMU-2024-XKDF-1002).”

FundingFind in source

PASSReviewer 2· 90% conf

Methods are detailed, the trial is registered (NCT05141435), CONSORT is followed, negative results are reported transparently, limitations are discussed, and funding/COI statements are present.

Evidence

“Trial registration ClinicalTrials.gov NCT05141435 (https://clinicaltrials.gov/ct2/show/NCT05141435)”

AbstractFind in source

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

MethodsFind in source

“The study was partially funded by National Key Research and Development Program of China (No 2022YFC2704803)”

FundingFind in source

PASSReviewer 3· 90% conf

Methods are replicable, the trial is registered (NCT05141435), CONSORT compliance is stated, all outcomes including nulls are reported, limitations are discussed extensively, conclusions are proportional, and funding/COI are declared.

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

19 minor

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

No major wording or formatting errors. 19 minor suggestions below.

19 copyedit issues flagged: mostly punctuation, consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

As a post-publication audit, this paper is methodologically robust. An informed reader should weigh the two minor reporting gaps: the ethics statement lacks a named framework (Declaration of Helsinki/ICH-GCP), and the analysis code is only in supplemental files rather than a version-controlled repository. These are not validity threats but suggest that a correction or erratum could improve transparency. The primary findings appear reliable based on the statistical recomputation checks and the overall study design.

1.
HIGHethics
Add an explicit statement of compliance with a named regulatory framework (e.g., Declaration of Helsinki and/or ICH-GCP) to the ethics section.
The current statement only references 'relevant local regulations' and CONSORT, which is a reporting guideline, not an ethics framework; this is a common expectation for human trials.
2.
HIGHdata code
Deposit the analysis code in a version-controlled public repository (e.g., GitHub, Zenodo) with a permanent DOI and link to the data, and update the data availability statement accordingly.
Providing code only in supplemental files lacks versioning and a persistent identifier, reducing reproducibility and discoverability.
3.
HIGHreporting
Correct the unit label for FiO2 in Table 1 from 'mm Hg' to a fraction (or remove the unit), as FiO2 is a proportion, not a pressure.
This mislabeling could confuse readers about the nature of the variable.
4.
HIGHcopyedit
Remove the stray unrelated DOI (10.1001/jamanetworkopen.2021.18904) from the data availability statement, and ensure only the correct Mendeley DOI appears.
This appears to be a copy-paste artifact and could be misinterpreted as a related publication.
5.
HIGHcopyedit
Remove the duplicate Data Availability Statement block in the Associated Data section to avoid redundancy.
The statement appears twice verbatim, which is untidy and may confuse readers.
6.
MEDIUMcopyedit
Fix the stray backtick in the abstract: change '27 of` 170 infants' to '27 of 170 infants'.
Typographical error.
7.
MEDIUMcopyedit
Remove the extra closing parenthesis in the primary outcome sentence: change 'P=0.007; )' to 'P=0.007).' (and similarly for the secondary outcome 'P=0.008; )').
Punctuation error.
8.
MEDIUMreporting
Add an explicit statement of race/ethnicity in the demographics table (e.g., 'Chinese, n (%)') to improve generalizability reporting.
Although the population is implicitly Chinese, explicit reporting is standard practice for human studies.
9.
MEDIUMcopyedit
Fix the footnote in Table 3: change '* Risk difference reported as median (interquartile range)' to '* Median difference reported as median (interquartile range)' for continuous variable rows.
The current footnote is inconsistent with the data presented (median differences for continuous outcomes).
10.
MEDIUMcopyedit
Fix the misspelling of 'Yunnan' in affiliation 12 (currently 'Yunan') and 'Research' in affiliation 7 (currently 'Resrach').
Geographic and institutional name errors.
11.
LOWcopyedit
Add a colon after the heading 'Caffeine administration' in the Methods section: change 'Caffeine administration Prophylactic...' to 'Caffeine administration: Prophylactic...'.
Improves readability.
12.
LOWcopyedit
Remove the empty parenthesis at the end of the sentence in Results, Study population: 'included in the final analysis ().'
Typographical artifact.
13.
LOWcopyedit
Consider replacing the semicolon after '89-94%' with a comma or period for better flow in the inclusion criteria list.
Minor punctuation improvement.

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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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Issued Aug 10, 2026Engine 7.29.0

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Kaimen Rigor review

Kaimen Rigor reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ReportingEthical approvals partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.29.0Source: full text

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 06Copyedit19 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 11 tests: 11 consistent, 0 inconsistent; 11 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

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

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

Data authenticity concerns

1 finding · worst low

Other integrity concernAssessed

3 integrity concerns flagged (0 high).

Reporting gaps

2 findings · worst medium

Data/code availability incompleteAssessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 2 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes its premise by citing prior work, outlining the limitations of current treatments, and providing a logical rationale for investigating NHFOV.

Evidence

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

Introduction ¶4Find in source

Introduction ¶3Find in source

“However, its efficacy as primary respiratory support for respiratory distress syndrome in preterm infants remains unproven.”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

The premise is well established: prior guidelines, epidemiological context, and prior RCTs with inconsistent findings are cited, and a clear hypothesis follows.

Evidence

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

Introduction ¶4Find 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

“Importantly, our study design addressed a key historical limitation in comparing NHFOV and NCPAP: variability in applied airway pressures.”

DiscussionFind in source

PASSReviewer 3· 90% conf

Evidence

“European consensus guidelines recommend nasal continuous positive airway pressure (NCPAP) as the preferred first line respiratory support strategy”

IntroductionFind in source

“However, its efficacy as primary respiratory support for respiratory distress syndrome in preterm infants remains unproven.”

IntroductionFind in source

“We hypothesised that NHFOV would be more effective than NCPAP in reducing treatment failure within 72 hours after birth”

IntroductionFind 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 (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

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.”

Methods ¶1Find in source

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

Methods ¶1Find 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 analysis ¶1Find in source

PASSReviewer 2· 85% conf

Randomization method, unit, masking, power analysis, and inclusion/exclusion criteria are all reported adequately; ITT analysis is stated.

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 3· 90% conf

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

“With a significance level (α) of 0.05 and 90% power, a sample size of 170 newborns per group was required”

Statistical analysisFind in source

paraphrase[Methods, Randomisation and masking]

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study adequately reports key demographic and biological characteristics of the human participants, including gestational age, birth weight, and sex.

Evidence

paraphrase[Table 1]

“Gestational age (weeks), median (IQR) | 27.0 (26.0-28.0) | 27.0 (26.0-28.0) | Birth weight (g), median (IQR) | 990 (820-1100) | 970 (880-1090)”

“Female | 74 (43.5) | 68 (39.5)”

Table 1Find in source

paraphrase[Table 1]

PASSReviewer 2· 85% conf

Sex, gestational age, birth weight, and key clinical characteristics are reported in baseline tables; both sexes are enrolled so no single-sex justification is needed.

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 3· 85% conf

Sex, gestational age, birth weight, and health status are reported in baseline tables; the cohort is an all-Chinese preterm population. Race/ethnicity is not explicitly stated, a minor gap.

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

absence[Methods, Study design]

Race/ethnicity is not explicitly reported (population is Chinese by setting).

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study explicitly states ethical approval from a named committee, provides a protocol number, and confirms informed consent was obtained from parents or guardians.

Evidence

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

Methods ¶1Find in source

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

Methods ¶1Find in source

WARNReviewer 2· 70% conf

IRB approval (named committee with protocol number) and written informed consent are clearly reported, but no named regulatory framework (e.g., Declaration of Helsinki, ICH-GCP) is cited.

Evidence

“The protocol was approved by the Ethics Committee of the Children’s Hospital of Chongqing Medical University (No 2019.161) and local institutional review boards of the participating centres.”

EthicsFind in source

“All parents or guardians provided written informed consent.”

EthicsFind in source

“data were anonymised in accordance with relevant local regulations.”

MethodsFind in source

WARNReviewer 3· 70% conf

Evidence

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

MethodsFind in source

“All parents or guardians provided written informed consent.”

EthicsFind in source

“data were anonymised in accordance with relevant local regulations. The trial was conducted in compliance with CONSORT”

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 (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Key reagents and equipment, including specific ventilation devices and medications, are identified with manufacturer information. Statistical software and version are also reported.

Evidence

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

Methods ¶2Find in source

Methods ¶3Find in source

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

Statistical analysis ¶3Find in source

PASSReviewer 2· 80% conf

The investigational devices and key pharmaceuticals are identified with manufacturers, and analysis software (R 4.4.2) is named; bench-science criteria are not applicable.

Evidence

MethodsFind in source

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

Statistical analysisFind in source

PASSReviewer 3· 80% conf

The investigational devices (ventilators) and co-interventions (surfactant, caffeine) are identified with manufacturer/source and dosing, and the analysis software is versioned.

Evidence

paraphrase[Methods, Study procedure]

“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 verifiedNOT REPORTED

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

Statistical analysis ¶2Find in source

Results ¶1Find in source

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

Statistical analysis ¶3Find in source

PASSReviewer 2· 85% conf

Tests are named, exact p-values and effect sizes with 95% CIs are reported, software is identified, and all reported percentages are arithmetically consistent.

Evidence

Statistical analysisFind in source

ResultsFind in source

PASSReviewer 3· 90% conf

Tests are named, exact p-values and effect sizes with 95% CIs are reported, software is versioned, and the reported proportions are arithmetically plausible against the stated denominators.

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”

Statistical analysisFind in source

paraphrase[Results, Primary outcome]

“Female | 74 (43.5) | 68 (39.5)”

Table 1Find in source

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper includes a data availability statement, provides a public repository link with a DOI for the data, and states that 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

WARNReviewer 2· 80% conf

Data are deposited in Mendeley Data with a DOI, but the analysis code is only available in supplemental files rather than a version-controlled public repository with a persistent identifier.

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”

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

WARNReviewer 3· 85% conf

Data are openly deposited in Mendeley with a DOI, but the analysis code is only placed in 'supplemental files' rather than a version-controlled public repository with a permanent identifier.

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”

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

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study provides sufficient methodological detail for replication, is registered as a clinical trial, references CONSORT guidelines, discusses limitations, and includes funding and COI statements.

Evidence

“Trial registration ClinicalTrials.gov NCT05141435 (https://clinicaltrials.gov/ct2/show/NCT05141435)”

AbstractFind in source

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

Methods ¶1Find in source

Limitations ¶1Find in source

FundingFind in source

PASSReviewer 2· 90% conf

Methods are detailed, the trial is registered (NCT05141435), CONSORT is followed, negative results are reported transparently, limitations are discussed, and funding/COI statements are present.

Evidence

“Trial registration ClinicalTrials.gov NCT05141435 (https://clinicaltrials.gov/ct2/show/NCT05141435)”

AbstractFind in source

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

MethodsFind in source

“The study was partially funded by National Key Research and Development Program of China (No 2022YFC2704803)”

FundingFind in source

PASSReviewer 3· 90% conf

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

19 minor

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

No major wording or formatting errors. 19 minor suggestions below.

19 copyedit issues flagged: mostly punctuation, consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHethics
Add an explicit statement of compliance with a named regulatory framework (e.g., Declaration of Helsinki and/or ICH-GCP) to the ethics section.
The current statement only references 'relevant local regulations' and CONSORT, which is a reporting guideline, not an ethics framework; this is a common expectation for human trials.
2.
HIGHdata code
Deposit the analysis code in a version-controlled public repository (e.g., GitHub, Zenodo) with a permanent DOI and link to the data, and update the data availability statement accordingly.
Providing code only in supplemental files lacks versioning and a persistent identifier, reducing reproducibility and discoverability.
3.
HIGHreporting
Correct the unit label for FiO2 in Table 1 from 'mm Hg' to a fraction (or remove the unit), as FiO2 is a proportion, not a pressure.
This mislabeling could confuse readers about the nature of the variable.
4.
HIGHcopyedit
Remove the stray unrelated DOI (10.1001/jamanetworkopen.2021.18904) from the data availability statement, and ensure only the correct Mendeley DOI appears.
This appears to be a copy-paste artifact and could be misinterpreted as a related publication.
5.
HIGHcopyedit
Remove the duplicate Data Availability Statement block in the Associated Data section to avoid redundancy.
The statement appears twice verbatim, which is untidy and may confuse readers.
6.
MEDIUMcopyedit
Fix the stray backtick in the abstract: change '27 of` 170 infants' to '27 of 170 infants'.
Typographical error.
7.
MEDIUMcopyedit
Remove the extra closing parenthesis in the primary outcome sentence: change 'P=0.007; )' to 'P=0.007).' (and similarly for the secondary outcome 'P=0.008; )').
Punctuation error.
8.
MEDIUMreporting
Add an explicit statement of race/ethnicity in the demographics table (e.g., 'Chinese, n (%)') to improve generalizability reporting.
Although the population is implicitly Chinese, explicit reporting is standard practice for human studies.
9.
MEDIUMcopyedit
Fix the footnote in Table 3: change '* Risk difference reported as median (interquartile range)' to '* Median difference reported as median (interquartile range)' for continuous variable rows.
The current footnote is inconsistent with the data presented (median differences for continuous outcomes).
10.
MEDIUMcopyedit
Fix the misspelling of 'Yunnan' in affiliation 12 (currently 'Yunan') and 'Research' in affiliation 7 (currently 'Resrach').
Geographic and institutional name errors.
11.
LOWcopyedit
Add a colon after the heading 'Caffeine administration' in the Methods section: change 'Caffeine administration Prophylactic...' to 'Caffeine administration: Prophylactic...'.
Improves readability.
12.
LOWcopyedit
Remove the empty parenthesis at the end of the sentence in Results, Study population: 'included in the final analysis ().'
Typographical artifact.
13.
LOWcopyedit
Consider replacing the semicolon after '89-94%' with a comma or period for better flow in the inclusion criteria list.
Minor punctuation improvement.

Full text (41,073 chars)Analyzed: Aug 10, 2026