Trial reportJournal of perinatology : official journal of the California Perinatal Association2019
Comparative effectiveness of drugs used to constrict the patent ductus arteriosus: a secondary analysis of the PDA-TOLERATE trial (NCT01958320).
Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01958320 (Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial), which is not on this map. Cited by 38 papers, 5 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.
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial
Who cites it
38 citing papers in PubMed, 5 syntheses or guidelines pooled it, 63 citations in OpenAlex.
- Pooled it
- Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants.The Cochrane database of systematic reviews · 2022Pooled it
- Dual medication therapy (acetaminophen and ibuprofen) for the management of patent ductus arteriosus in preterm infants: a systematic review and meta-analysis.Journal of perinatology : official journal of the California Perinatal Association · 2022Pooled it
- Efficacy and Costs of Three Pharmacotherapies for Patent Ductus Arteriosus Closure in Premature Infants.Paediatric drugs · 2022Pooled it
- The efficacy and safety of oral paracetamol versus oral ibuprofen for patent ductus arteriosus closure in preterm neonates - A systematic review and meta-analysis.Indian heart journalPooled it
- Cluster-randomized evaluation of neonatal intensive care unit quality improvement interventions in extremely preterm infants: secondary analysis of the INTACT trial.BMC pediatrics · 2026Trial
- The efficiency and safety of low-dose intravenous indomethacin for closure of patent ductus arteriosus in preterm neonate: a randomized controlled trial.Scientific reports · 2025Trial
- A randomized trial of intravenous acetaminophen versus indomethacin for treatment of hemodynamically significant PDAs in VLBW infants.Journal of perinatology : official journal of the California Perinatal Association · 2021Trial
- Effectiveness and safety of rectal dexibuprofen versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants with gestational age<34 weeks: A pilot study.International journal of immunopathology and pharmacologyTrial
- Acetaminophen versus Ibuprofen for the management of hemodynamically significant patent ductus arteriosus in very low birth weight infants: randomized trial.Jornal de pediatriaTrial
- Paracetamol as analgesic and risk of bronchopulmonary dysplasia in extremely preterm infants: a secondary analysis of the BeNeDuctus trial.Pediatric research · 2026Article
- The clinical utility of paracetamol serum concentration monitoring for patent ductus arteriosus treatment in preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Standard versus restricted fluid administration in preterm infants undergoing pharmacological treatment for haemodynamically significant patent ductus arteriosus.Pediatric research · 2026Article
- Management of patent ductus arteriosus in preterm neonates ≤32 weeks: a national survey of physician practices in Indian NICUs.Frontiers in pediatrics · 2026Article
- Management of the patent ductus arteriosus among infants born at 23 to 32 weeks' gestation between 2011 to 2022: a report from in the Children's Hospitals Neonatal Consortium.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- SCAI Position Statement on Transcatheter Occlusion of Patent Ductus Arteriosus in Premature Infants.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Article
- Response of the ductus arteriosus to acetaminophen or indomethacin in extremely low birth weight infants.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Acetaminophen for Patent Ductus Arteriosus and Risk of Mortality and Pulmonary Morbidity.Pediatrics · 2024Article
- Acetaminophen for the patent ductus arteriosus: has safety been adequately demonstrated?Journal of perinatology : official journal of the California Perinatal Association · 2023Review
- Evaluation of the Closure of Patent Ductus Arteriosus With Ibuprofen Compared to Indomethacin.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 17 institutions in 4 countries.
Funding
Abstract
objectiveTo evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks.
methodsWe performed a secondary analysis of the multi-center PDA-TOLERATE trial (NCT01958320). Infants with moderate-to-large PDAs were randomized 1:1 at 8.1 ± 2.1 days to either Drug treatment (n = 104) or Conservative management (n = 98). Drug treatments were assigned by center rather than within center (acetaminophen: 5 centers, 27 infants; ibuprofen: 7 centers, 38 infants; indomethacin: 7 centers, 39 infants).
resultsIndomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95% CI) = 3.21 (2.05-5.01)), followed by ibuprofen = 2.03 (1.05-3.91), and acetaminophen = 1.33 (0.55-3.24). The initial rate of acetaminophen-induced constriction was 27%. Infants with persistent moderate-to-large PDA after acetaminophen were treated with indomethacin. The final rate of constriction after acetaminophen ± indomethacin was 60% (similar to the rate in infants receiving indomethacin-alone (62%)).
conclusionIndomethacin was more effective than acetaminophen in producing ductus constriction.
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What OpenQuestion holds
Registered trials
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.