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Kaimen Rigor review

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.

DOI: 10.1136/bmj-2025-085569
Record issued: 2026-08-10
Engine: 7.29.0
Exported: 2026-09-22

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/73e3dad1-4ce3-4c93-a092-1a4f3d5f7529 is authoritative.

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.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p = .007 · recomputed p = .007Reviewers 1, 2
Primary outcome: Treatment failure within 72 hours (NHFOV vs NCPAP)
“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; ).”
Find in source
Taken as given: The counts 27/170 and 48/172 represent event counts and total N for two independent groups.; The test used was a chi-squared test for independence.
Method: Pearson's Chi-squared test, two-tailed
How we recomputed it: pChi2x2(27, 170-27, 48, 172-48)
CONSISTENTreported p = .008 · recomputed p = .009Reviewer 1
Secondary outcome: Treatment failure within seven days (NHFOV vs NCPAP)
“Treatment failure within seven days after birth was reported in 36 of 170 infants (21.2%) in the NHFOV group and 58 of 172 (33.7%) in the NCPAP group (risk difference −12.5 percentage points, 95% confidence interval −21.9 to −3.2; P=0.008; ).”
Find in source
Taken as given: The counts 36/170 and 58/172 represent event counts and total N for two independent groups.; The test used was a chi-squared test for independence.
Method: Pearson's Chi-squared test, two-tailed
How we recomputed it: pChi2x2(36, 170-36, 58, 172-58)
CONSISTENTreported p = .050 · recomputed p = .054Reviewer 1
Reason for treatment failure: Refractory hypoxia (NHFOV vs NCPAP)
“Refractory hypoxia | 19 (11.2) | 32 (18.6) | −7.4 (−14.9 to 0.1) | 0.05 |”
Find in source
Taken as given: The counts 19/170 and 32/172 represent event counts and total N for two independent groups.; The test used was a chi-squared test for independence.
Method: Pearson's Chi-squared test, two-tailed
How we recomputed it: pChi2x2(19, 170-19, 32, 172-32)
CONSISTENTreported p = .007 · recomputed p = .007Reviewer 2
Primary outcome: Pearson chi-square on the 2x2 table (27/170 vs 48/172)
“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”
Find in source
Taken as given: 27 and 48 are the event counts in the NHFOV and NCPAP arms respectively; The group totals are 170 and 172, giving non-events 143 and 124; df = 1 because the table is 2x2; the test is two-sided Pearson chi-square
Method: Pearson chi-square test on the 2x2 cell counts.
How we recomputed it: pChi2x2(27, 143, 48, 124)
CONSISTENTreported p = .008 · recomputed p = .009Reviewer 2
Secondary outcome: risk difference in treatment failure within seven days
“Treatment failure within seven days was also lower in the NHFOV group (−12.5 percentage points, 95% confidence interval −21.9 to −3.2; P=0.008”
Find in source
Taken as given: The −12.5 is the difference in percentage points between the two groups; The CI is two-sided at 95%; The test is a two-sided test of a difference of two proportions
Method: Back-derived p-value from the estimate and 95% CI using a normal approximation.
How we recomputed it: pCI(-12.5, -21.9, -3.2, 0)
CONSISTENTreported p = .008 · recomputed p = .009Reviewer 2
Secondary outcome: Pearson chi-square on the seven-day failure 2x2 table (36/170 vs 58/172)
“Treatment failure within seven days after birth was reported in 36 of 170 infants (21.2%) in the NHFOV group and 58 of 172 (33.7%) in the NCPAP group (risk difference −12.5 percentage points, 95% confidence interval −21.9 to −3.2; P=0.008”
Find in source
Taken as given: 36 and 58 are the event counts in the NHFOV and NCPAP arms respectively; The group totals are 170 and 172, giving non-events 134 and 114; df = 1 because the table is 2x2; the test is two-sided Pearson chi-square
Method: Pearson chi-square test on the 2x2 cell counts.
How we recomputed it: pChi2x2(36, 134, 58, 114)
CONSISTENTreported p = .050 · recomputed p = .053Reviewer 2
Secondary outcome: risk difference in refractory hypoxia (treatment failure reason)
“those with reported hypoxia seemed to have borderline reduction in risk in the NHFOV group compared with the NCPAP group (−7.4 percentage points, 95% confidence interval −14.9 to 0.1; P=0.05;”
Find in source
Taken as given: The −7.4 is the difference in percentage points between the two groups; The CI is two-sided at 95%; The test is a two-sided test of a difference of two proportions
Method: Back-derived p-value from the estimate and 95% CI using a normal approximation.
How we recomputed it: pCI(-7.4, -14.9, 0.1, 0)
CONSISTENTreported p = .007 · recomputed p = .007Reviewer 3
Primary outcome: χ² test on 2×2 table (treatment failure within 72h, NHFOV 27/170 vs NCPAP 48/172).
“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)”
Find in source
Taken as given: The 27 and 48 are the event counts in the NHFOV and NCPAP groups respectively; The 170 and 172 are the group totals; The non-event counts are 143 (=170−27) and 124 (=172−48); df = 1 because the table is 2×2; The paper used a χ² test for dichotomous outcomes
Method: Pearson χ² on the 2×2 table from cell counts, two-tailed, df=1; p≈0.0072, consistent with reported P=0.007.
How we recomputed it: pChi2x2(27,143,48,124)
CONSISTENTreported p = .007 · recomputed p = .007Reviewer 3
Primary outcome risk difference, p derived from estimate and 95% CI.
“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)”
Find in source
Taken as given: −12.0 is the risk difference in percentage points; −20.7 and −3.4 are the lower and upper bounds of a two-sided 95% CI; log=0 because the estimate is a difference, not a ratio
Method: Two-tailed normal-approximation p from the estimate and 95% CI width; p≈0.0065, consistent with reported P=0.007.
How we recomputed it: pCI(-12.0, -20.7, -3.4, 0)
CONSISTENTreported p = .008 · recomputed p = .009Reviewer 3
Secondary outcome: treatment failure within 7 days, 2×2 χ² test (36/170 vs 58/172).
“Treatment failure within seven days after birth was reported in 36 of 170 infants (21.2%) in the NHFOV group and 58 of 172 (33.7%) in the NCPAP group (risk difference −12.5 percentage points, 95% confidence interval −21.9 to −3.2; P=0.008)”
Find in source
Taken as given: The 36 and 58 are the event counts in the NHFOV and NCPAP groups respectively; The 170 and 172 are the group totals; The non-event counts are 134 (=170−36) and 114 (=172−58); df = 1 because the table is 2×2; The paper used a χ² test for dichotomous outcomes
Method: Pearson χ² on the 2×2 table, two-tailed, df=1; p≈0.0093, close to reported P=0.008, within rounding.
How we recomputed it: pChi2x2(36,134,58,114)
CONSISTENTreported p = .008 · recomputed p = .009Reviewer 3
Secondary outcome risk difference at 7 days, p derived from estimate and 95% CI.
“Treatment failure within seven days after birth was reported in 36 of 170 infants (21.2%) in the NHFOV group and 58 of 172 (33.7%) in the NCPAP group (risk difference −12.5 percentage points, 95% confidence interval −21.9 to −3.2; P=0.008)”
Find in source
Taken as given: −12.5 is the risk difference in percentage points; −21.9 and −3.2 are the lower and upper bounds of a two-sided 95% CI; log=0 because the estimate is a difference, not a ratio
Method: Two-tailed normal-approximation p from the estimate and 95% CI width; p≈0.0088, consistent with reported P=0.008.
How we recomputed it: pCI(-12.5, -21.9, -3.2, 0)

lowinternal contradiction
Baseline characteristics were not perfectly balanced: CRIB II score (P=0.05) and PaO2 before enrolment (P=0.02) were significantly higher in the NHFOV group; the authors disclose this and ran sensitivity analyses adjusting for them, so it is reported transparently rather than concealed.
“Baseline characteristics were well balanced between the two groups except for clinical risk index for babies II score (P=0.05) and PaO 2 before enrolment (P=0.02), which is significantly higher in the NHFOV group”
ResultsFind in source

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.

partialReviewer 1
Our findings corroborate and extend the conclusions of two recent meta-analyses, and provide new insights into NHFOV’s potential use in managing respiratory distress syndrome in this vulnerable population.
The study's findings align with some prior research and meta-analyses, but the claim of 'new insights' is a bit strong given the inconsistent findings in the field and the study's own limitations regarding generalizability to diverse populations.
Evidence: Discussion, Comparison with other studies, paragraph 1
“Our findings corroborate and extend the conclusions of two recent meta-analyses, and provide new insights into NHFOV’s potential use in managing respiratory distress syndrome in this vulnerable population.”
Discussion ¶1Find in source
partialReviewer 3
The null bronchopulmonary dysplasia result is attributable at least in part to the trial being underpowered for this secondary outcome.
The paper states the trial was underpowered for BPD as a secondary outcome and notes a non-significant reduction; this is a reasonable interpretation but is an inference, not a demonstrated cause.
Evidence: BPD incidence 65/170 (38.2%) vs 77/172 (44.8%), risk difference −6.5 pp (95% CI −17.0 to 3.9; P=0.22); author states 'our trial was underpowered for bronchopulmonary dysplasia as a secondary outcome'.
“Secondly, our trial was underpowered for bronchopulmonary dysplasia as a secondary outcome.”
DiscussionFind in source
supportedReviewer 1
NHFOV is more efficacious than NCPAP in reducing invasive mechanical ventilation as primary respiratory support for extremely preterm infants with respiratory distress syndrome.
The primary outcome results directly support this claim, showing a statistically significant reduction in treatment failure (need for invasive mechanical ventilation) in the NHFOV group.
Evidence: Results, Primary outcome, paragraph 1; Table 2
“To test the hypothesis that non-invasive high frequency oscillatory ventilation (NHFOV) is more efficacious than nasal continuous positive airway pressure (NCPAP) in reducing invasive mechanical ventilation as primary respiratory support for extremely preterm infants with respiratory distress syndrome.”
AbstractFind in source
supportedReviewer 1
Treatment failure within 72 hours occurred in 27 of 170 infants (15.9%) in the NHFOV group and 48 of 172 infants (27.9%) in the NCPAP group (risk difference −12.0 percentage points, 95% confidence interval −20.7 to −3.4; P=0.007).
This is a direct reporting of the primary outcome, which is clearly presented in the results section and Table 2.
Evidence: Results, Primary outcome, paragraph 1; Table 2
“Treatment failure within 72 hours occurred in 27 of` 170 infants (15.9%) in the NHFOV group and 48 of 172 infants (27.9%) in the NCPAP group (risk difference −12.0 percentage points, 95% confidence interval −20.7 to −3.4; P=0.007).”
AbstractFind in source
supportedReviewers 1, 3
Both techniques did not show significant differences in neonatal adverse events.
The safety outcomes section and Table 3 show no significant differences in various adverse events between the two groups, directly supporting this claim.
Evidence: Results, Safety outcomes, paragraph 1; Table 3
“Both techniques did not show significant differences in neonatal adverse events.”
ConclusionFind in source
supportedReviewers 1, 2, 3
NHFOV appeared superior to NCPAP in reducing the need for intubation when used as a primary respiratory support strategy in extremely preterm infants.
This conclusion is directly supported by the statistically significant reduction in treatment failure (defined as need for invasive mechanical ventilation) in the NHFOV group.
Evidence: Results, Primary outcome, paragraph 1; Table 2
“NHFOV appeared superior to NCPAP in reducing the need for intubation when used as a primary respiratory support strategy in extremely preterm infants.”
ConclusionFind in source
supportedReviewer 1
Our trial was underpowered for bronchopulmonary dysplasia as a secondary outcome.
The discussion explicitly states that the trial was underpowered for this specific secondary outcome, which is a transparent and supported limitation.
Evidence: Discussion, Comparison with other studies, paragraph 2
“Secondly, our trial was underpowered for bronchopulmonary dysplasia as a secondary outcome.”
Discussion ¶2Find in source
supportedReviewer 2
Treatment failure within seven days was also lower with NHFOV.
The secondary outcome provides a significant result consistent with the claim.
Evidence: 36/170 (21.2%) vs 58/172 (33.7%), risk difference −12.5 (−21.9 to −3.2), P=0.008.
“Treatment failure within seven days after birth was reported in 36 of 170 infants (21.2%) in the NHFOV group and 58 of 172 (33.7%) in the NCPAP group”
ResultsFind in source
supportedReviewers 2, 3
Both respiratory support techniques were equally safe (no significant differences in neonatal adverse events).
No significant differences were found in the reported safety outcomes, supporting the claim.
Evidence: Table 3 safety outcomes: air leaks, thick secretions, death in hospital, and nasal injury all non-significant (P=0.18 to 0.64).
“Both techniques did not show significant differences in neonatal adverse events.”
AbstractFind in source
supportedReviewer 2
NHFOV is feasible and potentially advantageous as a primary respiratory treatment for extremely preterm infants.
The primary-result reduction in intubation and comparable safety profile back this claim, which is appropriately hedged.
Evidence: Primary outcome reduction and comparable adverse-event rates across the trial.
“The results advance our current understanding by showing that NHFOV is feasible and potentially advantageous as a primary respiratory treatment for extremely preterm infants”
DiscussionFind in source
supportedReviewer 2
The findings corroborate and extend two recent meta-analyses.
The Discussion contextualises the results against prior RCTs and meta-analyses consistently, supporting the claim.
Evidence: Discussion comparison with Malakian, Iranpour, Zhu, Mukerji, Rüegger, Klotz trials and two meta-analyses.
“Our findings corroborate and extend the conclusions of two recent meta-analyses, and provide new insights into NHFOV’s potential use in managing respiratory distress syndrome in this vulnerable population.”
DiscussionFind in source
supportedReviewer 3
NHFOV reduced treatment failure within seven days compared with NCPAP.
The secondary outcome is significant and reported with CI.
Evidence: 36/170 (21.2%) vs 58/172 (33.7%), risk difference −12.5 pp (95% CI −21.9 to −3.2; P=0.008).
Treatment failure within seven days after birth was reported in 36 of 170 infants (21.2%) in the NHFOV group and 58 of 172 (33.7%) in the NCPAP group (risk difference −12.5 percentage points, 95% confidence interval −21.9 to −3.2; P=0.008)
Resultsreviewer’s wording

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

N/ASurrogate endpoint
The primary efficacy outcome is a hard clinical outcome: the need for invasive mechanical ventilation within 72 hours after birth. No surrogate or biomarker is used as the primary basis for the efficacy claim.
“The primary outcome was respiratory support failure, defined by the need for invasive mechanical ventilation within 72 hours after birth.”
Find in source
ADEQUATEEffect size
The primary effect is a 12.0 percentage point absolute reduction in treatment failure (from 27.9% to 15.9%), which is statistically significant and clinically meaningful because it reflects avoidance of intubation in extremely preterm infants. The magnitude is substantial and not a small fraction of any reference value.
“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).”
Find in source

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).

lowother
The data availability statement contains a stray, unrelated DOI (10.1001/jamanetworkopen.2021.18904) embedded mid-sentence, which appears to be a copy/paste artifact rather than a validity threat.
“can be found at https://data.mendeley.com/datasets/66gc4zb37c/1 (10.1001/jamanetworkopen.2021.18904)”
Data availabilityFind in source
lowother
The baseline table labels FiO2 with the unit 'mm Hg', but FiO2 is a fraction (values are 0.3), indicating a mislabeled unit in Table 1.
“FiO 2 before enrolment (mm Hg), median (IQR) | 0.3 (0.2-0.3)”
Table 1Find in source

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.

ClinicalTrials.gov

NCT05141435

Reporting guidelines: 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).

NO DOI
Practice of Neonatology
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

2 data/code links checked; 2 live.

datahttps://clinicaltrials.gov/ct2/show/NCT05141435LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
dataMendeley DataLIVEHTTP 200
https://data.mendeley.com/datasets/66gc4zb37c/1
Resolves to Mendeley Data (data repository).

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.

MINORpunctuationAbstract, Results
“27 of` 170 infants”
→ 27 of 170 infants
Typo: backtick character before '170'.
MINORconsistencyAbstract, Trial registration
“Accepted 2025 Aug 15; Collection date 2025.”
→ Accepted [Date]; Collection date [Date].
The accepted date and collection date are in the future (2025), which is likely a placeholder or error in the preprint.
MINORgrammarMethods, Study design, paragraph 1
“All authors reviewed the protocol and ensured adherence throughout the trial.”
→ All authors reviewed the protocol and ensured adherence to it throughout the trial.
Slightly awkward phrasing, 'to it' improves clarity.
MINORpunctuationMethods, Study participants, paragraph 1
“diagnosis of respiratory distress syndrome and prerandomisation support with NCPAP set at 6 cm H 2 O of positive end expiratory pressure (after delivery room stabilisation at 6-8 cm H 2 O per local guidelines) with a fraction of inspired oxygen (FiO 2 ) >0.25 to maintain a target peripheral oxygen saturation (SpO 2 ) of 89-94%; less than two hours after birth at the time of enrolment; and informed parental consent obtained before randomisation.”
→ diagnosis of respiratory distress syndrome and prerandomisation support with NCPAP set at 6 cm H 2 O of positive end expiratory pressure (after delivery room stabilisation at 6-8 cm H 2 O per local guidelines) with a fraction of inspired oxygen (FiO 2 ) >0.25 to maintain a target peripheral oxygen saturation (SpO 2 ) of 89-94%; less than two hours after birth at the time of enrolment; and informed parental consent obtained before randomisation.
The semicolon after '89-94%' should probably be a comma or removed for better flow, as the next clause is part of the same list of criteria.
MINORgrammarMethods, Study procedure, paragraph 4
“Caffeine administration Prophylactic caffeine treatment (caffeine citrate injection, Chiesi Pharmaceuticals, Parma, Italy) was administered within the first 24 hours after birth.”
→ Caffeine administration: Prophylactic caffeine treatment (caffeine citrate injection, Chiesi Pharmaceuticals, Parma, Italy) was administered within the first 24 hours after birth.
Add a colon after the heading 'Caffeine administration'.
MINORgrammarMethods, Other treatments, paragraph 1
“Antibiotics are frequently started in newborns with respiratory distress syndrome until sepsis is excluded.”
→ Antibiotics are frequently started in newborns with respiratory distress syndrome until sepsis is excluded.
Consider 'Antibiotics are frequently started for newborns...' or 'Antibiotics are frequently initiated in newborns...' for slightly improved phrasing.
MINORpunctuationResults, Study population, paragraph 1
“Consequently, data from 342 newborns were included in the final analysis ().”
→ Consequently, data from 342 newborns were included in the final analysis.
Empty parenthesis at the end of the sentence.
MINORpunctuationResults, Primary outcome, paragraph 1
“P=0.007; ).”
→ P=0.007).
Extra closing parenthesis.
MINORpunctuationResults, Secondary outcomes, paragraph 1
“P=0.008; ).”
→ P=0.008).
Extra closing parenthesis.
MINORconsistencyTable 3, footnote
“* Risk difference reported as median (interquartile range).”
→ * Median difference reported as median (interquartile range).
The row 'Time to surfactant administration (hours)' and 'Duration of supplemental oxygen (days)' report median (IQR) and the footnote refers to 'Risk difference reported as median (interquartile range)', which is inconsistent. It should refer to median difference for continuous variables.
MINORtypoAffiliation 7
“Agency for Science, Technology & Resrach (A*STAR)”
→ Agency for Science, Technology & Research (A*STAR)
Misspelling of 'Research'.
MINORtypoAffiliation 12
“Women and Children's Health Hospital of Qujing, Yunan, China”
→ Yunnan, China
Misspelling of the province name 'Yunnan'.
MINORconsistencyTable 1
“FiO 2 before enrolment (mm Hg), median (IQR) | 0.3 (0.2-0.3)”
→ Change the unit to a fraction (e.g., 'FiO 2 before enrolment, median (IQR)')
FiO2 is a fraction, not mm Hg; the unit label is incorrect.
MINORconsistencyAssociated Data section
“Data Availability Statement ... publicly available and can be found at https://data.mendeley.com/datasets/66gc4zb37c/1”
→ Remove the duplicated Data Availability Statement block
The Data Availability Statement text appears twice (main text and Associated Data section).
MINORpunctuationAbstract, Results
“Treatment failure within 72 hours occurred in 27 of` 170 infants”
→ Remove the stray backtick: '27 of 170 infants'
A stray backtick appears after 'of'.
MINORotherAssociated Data / Data Availability Statement
“can be found at https://data.mendeley.com/datasets/66gc4zb37c/1 (10.1001/jamanetworkopen.2021.18904)”
→ Remove the stray unrelated DOI '(10.1001/jamanetworkopen.2021.18904)' from the data statement.
An apparently unrelated JAMANetworkOpen DOI appears mid-sentence in the data availability statement; likely a template/citation leftover.
MINORtypoAuthor affiliations, item 3
“Women and Children's Health Hospital of Qujing, Yunan, China”
→ Change 'Yunan' to 'Yunnan'.
Misspelled province name.
MINORtypoAuthor affiliations, item 7
“Institute for Human Development & Potential (iHDP), Agency for Science, Technology & Resrach (A*STAR)”
→ Change 'Resrach' to 'Research'.
Misspelling in agency name.
MINORconsistencyData availability statement (body vs. Associated Data)
“can be found at https://data.mendeley.com/datasets/66gc4zb37c/1 ... or Zhu, Xingwang (2025)”
→ Keep a single, consistent data availability statement.
The data availability statement is duplicated verbatim in the body and in the Associated Data section.

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.

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

RigorReviewer 1

RigorReviewer 2

RigorReviewer 3

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

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.

DOI

10.1136/bmj-2025-085569

Record issued

2026-08-10

Engine

7.29.0

Exported

2026-09-22