Trial reportTrials2016
Efficacy and safety of intravenous paracetamol in comparison to ibuprofen for the treatment of patent ductus arteriosus in preterm infants: study protocol for a randomized control trial.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02422966 (Efficacy and Safety of Paracetamol in Comparison to Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants), which is not on this map. Cited by 10 papers.
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.
Efficacy and Safety of Paracetamol in Comparison to Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants: A Randomized, Open Label, Comparator-controlled, Prospective Study
Who cites it
10 citing papers in PubMed, 29 citations in OpenAlex.
- A pilot randomised blinded placebo-controlled trial of paracetamol for later treatment of a patent ductus arteriosus.Journal of perinatology : official journal of the California Perinatal Association · 2019Trial
- Evaluating the Effectiveness of Ibuprofen Versus Acetaminophen in Closing Patent Ductus Arteriosus in Preterm Neonates.Children (Basel, Switzerland) · 2026Article
- Racing against time: leveraging preclinical models to understand pulmonary susceptibility to perinatal acetaminophen exposures.American journal of physiology. Lung cellular and molecular physiology · 2022Review
- What Should be the First-line Treatment for the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants?Arquivos brasileiros de cardiologia · 2022Article
- Acetaminophen and the Developing Lung: Could There Be Lifelong Consequences?The Journal of pediatrics · 2021Review
- Comparison of Gastrointestinal Complications of Paracetamol and Ibuprofen in the Management of Infants with Patent Ductus Arteriosus: A Randomized Clinical Trial Study.International journal of preventive medicine · 2021Article
- Oral ibuprofen is superior to oral paracetamol for patent ductus arteriosus in very low and extremely low birth weight infants.Medicine · 2019Observational
- Low-dose intravenous acetaminophen versus oral ibuprofen for the closure of patent ductus arteriosus in premature neonates.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2019Article
- Efficacy of Paracetamol in Closure of Ductus Arteriosus in Infants under 32 Weeks of Gestation.Frontiers in pediatrics · 2018Article
- Paracetamol in Patent Ductus Arteriosus Treatment: Efficacious and Safe?BioMed research international · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatent ductus arteriosus (PDA) is one of most common complications in preterm infants. Although ibuprofen represents the first choice for the closure of PDA, this treatment can cause severe gastrointestinal and adverse renal effects and worsen platelet function. The successful closure of the PDA with paracetamol has been recently reported in several preterm infants, and the safety of paracetamol for this use has been suggested by the available data. METHODS/
designWe present the design of a randomized, multicenter, controlled study, whose aim is to assess the effectiveness and safety of intravenous paracetamol in comparison to intravenous ibuprofen for the treatment of PDA in preterm infants. A total of 110 infants born at 25(+0) to 31(+6) weeks of gestational age will be enrolled and randomized to receive paracetamol or ibuprofen (55 patients per group) starting at 24-72 h of life. The primary endpoint of the study is the comparison of the PDA closing rate observed after a 3-day course with paracetamol or ibuprofen. The secondary endpoints include the closure rate of PDA after the second course of treatment with ibuprofen, the re-opening rate of the PDA, the incidence of surgical ligation, and the occurrence of adverse effects. DISCUSSION: The results of this study will provide new information about the possible use of paracetamol in the treatment of PDA. Paracetamol could offer several important therapeutic advantages over current treatment options, and it could become the treatment of choice for the management of PDA, mainly due to its more favorable side effect profile.
trial registrationClinicaltrials.gov NCT02422966 . Eudract no. 2013-003883-30.
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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.