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

Name: Αlpha¹ Rigor Record — Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.
Item: Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.
Rating: 96
Author: Αlpha¹

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

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Αlpha¹ Rigor Review — 4.75★ (Strong), 0 critical, 2 high issues for “Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.”

Links back to this Rigor Record.

Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 16, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingData & code availability partially met−0.25★

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

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 8 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Problems surfaced1 type

Reporting gaps1

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

This Αlpha¹ Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted multicenter RCT with rigorous randomization, blinding, and statistical methods. The main weaknesses are the absence of a data availability statement and the lack of explicit ethics committee identification, both of which are reporting gaps rather than substantive flaws.

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

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

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

Reporting

Eight Dimensions7 pass · 1 warn

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

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

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

Evidence

direct quote[Introduction, paragraph 1-3]

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