Evidence map›Paper›PMID 38265644›Full record

Trial reportThe New England journal of medicine2024

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

Samir Gupta, Nimish V Subhedar, Jennifer L Bell, David Field, Ursula Bowler, Elizabeth Hutchison, Sam Johnson, Wilf Kelsall, Justine Pepperell, Tracy Roberts and 6 more

Open access · greenAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The New England journal of medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 68 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 4 pooled it
40.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 4 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Procedural closure of the patent ductus arteriosus in preterm infants: a clinical practice guideline.Journal of perinatology : official journal of the California Perinatal Association · 2024
    Guideline
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Current practices in the management of hemodynamically significant patent ductus arteriosus.Journal of perinatology : official journal of the California Perinatal Association · 2026
    Article
  13. Article
  14. Neonatal acute kidney injury and the patent ductus arteriosus.Pediatric nephrology (Berlin, Germany) · 2026
    Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article

8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 1 institution in 1 country.

Samir GuptaFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Nimish V SubhedarFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Jennifer L BellFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
David FieldFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Ursula BowlerFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Elizabeth HutchisonFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Sam JohnsonFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Wilf KelsallFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Justine PepperellFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Tracy RobertsFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Sunil SinhaFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Kayleigh StanburyFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Jonathan WyllieFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Pollyanna HardyFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Edmund JuszczakFrom the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
Baby-OSCAR Collaborative Group
University of Liverpool · GB

Funding

Department of Health 11/92/15NIHR Health Technology Assessment Programme 11/92/15
6 · The paper itself

Abstract

backgroundThe cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known.

methodsWe conducted a multicenter, randomized, double-blind, placebo-controlled trial evaluating early treatment (≤72 hours after birth) with ibuprofen for a large PDA (diameter of ≥1.5 mm with pulsatile flow) in extremely preterm infants (born between 23 weeks 0 days' and 28 weeks 6 days' gestation). The primary outcome was a composite of death or moderate or severe bronchopulmonary dysplasia evaluated at 36 weeks of postmenstrual age.

resultsA total of 326 infants were assigned to receive ibuprofen and 327 to receive placebo; 324 and 322, respectively, had data available for outcome analyses. A primary-outcome event occurred in 220 of 318 infants (69.2%) in the ibuprofen group and 202 of 318 infants (63.5%) in the placebo group (adjusted risk ratio, 1.09; 95% confidence interval [CI], 0.98 to 1.20; P = 0.10). A total of 44 of 323 infants (13.6%) in the ibuprofen group and 33 of 321 infants (10.3%) in the placebo group died (adjusted risk ratio, 1.32; 95% CI, 0.92 to 1.90). Among the infants who survived to 36 weeks of postmenstrual age, moderate or severe bronchopulmonary dysplasia occurred in 176 of 274 (64.2%) in the ibuprofen group and 169 of 285 (59.3%) in the placebo group (adjusted risk ratio, 1.09; 95% CI, 0.96 to 1.23). Two unforeseeable serious adverse events occurred that were possibly related to ibuprofen.

conclusionsThe risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age was not significantly lower among infants who received early treatment with ibuprofen than among those who received placebo. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Baby-OSCAR ISRCTN Registry number, ISRCTN84264977.).

Indexed as

Cyclooxygenase InhibitorsDuctus Arteriosus, PatentIbuprofenAnti-Inflammatory Agents, Non-SteroidalBronchopulmonary DysplasiaDouble-Blind MethodHumansInfant, Extremely PrematureInfant, NewbornTime FactorsTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalCyclooxygenase InhibitorsIbuprofen

Identifiers

PMID38265644
PMCPMC7615774
OpenAlexW4391160759

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.