Trial reportThe New England journal of medicine2024
Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.
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.
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.
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.
Who cites it
68 citing papers in PubMed, 4 syntheses or guidelines pooled it, 100 citations in OpenAlex.
- Early drug treatment in preterm patients with large patent ductus arteriosus at 28 weeks or less gestational age: systematic review and meta-analysis.Journal of perinatology : official journal of the California Perinatal Association · 2025Pooled it
- Beneficial vs harmful effects of pharmacological treatment of patent ductus arteriosus: A Bayesian meta-analysis.Pediatric research · 2025Pooled it
- Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants.The Cochrane database of systematic reviews · 2025Pooled it
- Procedural closure of the patent ductus arteriosus in preterm infants: a clinical practice guideline.Journal of perinatology : official journal of the California Perinatal Association · 2024Guideline
- [Expectant management versus acetaminophen for early treatment of hemodynamically significant patent ductus arteriosus in very preterm infants: a randomized controlled trial].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2026Trial
- Two-Year Outcomes of a Randomized Controlled Trial of Nonintervention Versus Oral Ibuprofen for Patent Ductus Arteriosus in Premature Infants.Journal of Korean medical science · 2026Trial
- Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial (Baby-OSCAR trial).Health technology assessment (Winchester, England) · 2026Trial
- Azithromycin therapy for prevention of chronic lung disease of prematurity (AZTEC): a randomised placebo-controlled trial.Health technology assessment (Winchester, England) · 2026Trial
- Patent Ductus Arteriosus, Hydrocortisone, and Outcome among Infants Born Extremely Preterm: Secondary Analysis of the Hydrocortisone Trial.The Journal of pediatrics · 2025Trial
- Paracetamol or ibuprofen? A pilot study comparing rescue therapy for PDA in preterm infants within the first month.Frontiers in pediatrics · 2025Trial
- Does use of acetaminophen and/or NSAIDs increase the risk of developing bronchopulmonary dysplasia?Pediatric research · 2026Article
- Current practices in the management of hemodynamically significant patent ductus arteriosus.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Variations in diagnosis and management of hemodynamically significant patent ductus arteriosus across neonatal intensive care units in the Children's Hospitals Neonatal Consortium.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Neonatal acute kidney injury and the patent ductus arteriosus.Pediatric nephrology (Berlin, Germany) · 2026Review
- EBNEO Commentary: Expectant Management Versus Medication for Patent Ductus Arteriosus in Preterm Infants-The PDA RCT.Acta paediatrica (Oslo, Norway : 1992) · 2026Article
- Making sense of the evidence: designing randomised controlled trials for preterm infants with high-shunt volume patent ductus arteriosus.Archives of disease in childhood. Fetal and neonatal edition · 2026Review
- Paracetamol as analgesic and risk of bronchopulmonary dysplasia in extremely preterm infants: a secondary analysis of the BeNeDuctus trial.Pediatric research · 2026Article
- PDA Treatment Strategy and Pulmonary Hemorrhage Risk in Very Low Birth Weight Infants: A Nationwide Cohort Study.Children (Basel, Switzerland) · 2026Article
- Expert consensus on bedside transcatheter closure of patent ductus arteriosus in extremely low birth weight infants.Pediatric research · 2026Article
- AI, machine learning, and adjudication of hemodynamically significant PDA in extremely premature infants.Pediatric research · 2026Article
8 more citing papers are in PubMed but not listed here.
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Authors and funding
16 authors at 1 institution in 1 country.
Funding
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.).
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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.