Evidence map›Paper›PMID 24223740›Full record

Trial reportPloS one2013

Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial.

Dan Dang, Dongxuan Wang, Chuan Zhang, Wenli Zhou, Qi Zhou, Hui Wu

3 registry-linked trialsOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 63 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 10 pooled it
11.9field-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.

NCT03103022 phase1completednot on this mapstarted 2017, after this paper: background citation

Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus in Premature Infants: A Pilot Study

TypeinterventionalSponsorUniversity of FloridaRan2017 to 2019Enrolled20ConditionsPatent Ductus Arteriosus, NeonateArmsAcetaminophen, ibuprofen
NCT03537144 phase3terminatednot on this mapstarted 2016, after this paper: background citation

Comparison of the Efficacy of IV Acetaminophen Versus IV Indomethacin in Treatment of Hemodynamically Significant PDA in VLBW Infants

TypeinterventionalSponsorUniversity of TennesseeRan2016 to 2018Enrolled37ConditionsPatent Ductus ArteriosusArmsIndomethacin, Acetaminophen
NCT04037514 phase3completednot on this mapstarted 2017, after this paper: background citation

Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus: a Randomized Clinical Trial

TypeinterventionalSponsorMáximo Vento TorresRan2017 to 2024Enrolled133ConditionsPatent Ductus Arteriosus After Premature BirthArmsParacetamol, Ibuprofen
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 10 syntheses or guidelines pooled it, 174 citations in OpenAlex.

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  11. 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 · 2021
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  13. 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 · 2019
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3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Dan DangDepartment of Neonatology, The First Hospital of Jilin University, Changchun, China.
Dongxuan Wang
Chuan Zhang
Wenli Zhou
Qi Zhou
Hui Wu
Jilin University · CNFirst Hospital of Jilin University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

TRIAL

designOral ibuprofen has demonstrated good effects on symptomatic patent ductus arteriosus (PDA) but with many contraindications and potential side-effects. In the past two years, oral paracetamol administration to several preterm infants with PDA has been reported. Here, a randomized, non-blinded, parallel-controlled and non-inferiority trial was designed to evaluate the efficacy and safety profiles of oral paracetamol to those of standard ibuprofen for PDA closure in premature infants.

methodsOne hundred and sixty infants (gestational age ≤ 34 weeks) with echocardiographically confirmed PDA were randomly assigned to receive either oral paracetamol (n = 80) or ibuprofen (n = 80). After the initial treatment course in both groups, the need for a second course was determined by echocardiographic evaluation. The main outcome was rate of ductal closure, and secondary outcomes were adverse effects and complications.

resultThe ductus was closed in 65 (81.2%) infants of the paracetamol group compared with 63 (78.8%) of the ibuprofen group. The 95% confidence interval of the difference between these groups was [-0.080,0.128], demonstrating that the effectiveness of paracetamol treatment was not inferior to that of ibuprofen. In fact, the incidence of hyperbilirubinemia or gastrointestinal bleeding in the paracetamol group was significantly lower than that of the ibuprofen group. No significant differences in other clinical side effects or complications were noted.

conclusionThis comparison of drug efficacy and safety profiles in premature infants with PDA revealed that oral paracetamol was comparable to ibuprofen in terms of the rate of ductal closure and even showed a decreased risk of hyperbilirubinemia or gastrointestinal bleeding. Therefore, paracetamol may be accepted as a first-line drug treatment for PDA in preterm infants.

trial registrationChiCTR.org ChiCTR-TRC-12002177.

Indexed as

AcetaminophenAdministration, OralDuctus Arteriosus, PatentFemaleGestational AgeHeartHumansIbuprofenInfant, NewbornInfant, PrematureMaleOliguriaTreatment OutcomeAcetaminophenIbuprofen

Identifiers

PMID24223740
PMCPMC3817181
OpenAlexW1984923791

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.