Evidence map›Paper›PMID 30323322›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2019

A pilot randomised blinded placebo-controlled trial of paracetamol for later treatment of a patent ductus arteriosus.

Martin Kluckow, Hazel Carlisle, Margaret Broom, Patricia Woods, Michele Jeffery, Deepa Desai, Yan Chen, Nick Evans

Erratum issuedAbstract readPragmatic Clinical Trial
PubMed Publisher
In one paragraph

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. An erratum has been issued. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
1.4field-weighted citation impact, top 17% 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

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Observational
  5. Acetaminophen for the patent ductus arteriosus: has safety been adequately demonstrated?Journal of perinatology : official journal of the California Perinatal Association · 2023
    Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Martin KluckowDepartment of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia. martin.kluckow@sydney.edu.au.
Hazel CarlisleThe Canberra Hospital, Canberra, ACT, Australia.
Margaret BroomThe Canberra Hospital, Canberra, ACT, Australia.
Patricia WoodsRoyal Prince Alfred Women and Babies Hospital and University of Sydney, Sydney, NSW, Australia.
Michele JefferyDepartment of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.
Deepa DesaiDepartment of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.
Yan ChenDepartment of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.
Nick EvansRoyal Prince Alfred Women and Babies Hospital and University of Sydney, Sydney, NSW, Australia.
University of Sydney · AUCanberra Hospital · AURoyal Prince Alfred Hospital · AURoyal North Shore Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo explore the efficacy and risks of oral paracetamol in later (>2 weeks old) treatment of patent ductus arteriosus (PDA). STUDY

designA multicentre double-blind placebo-controlled randomised pilot trial in three neonatal intensive care units in Australia. Infants born <33 weeks with haemodynamically significant PDA were treated with a 5-day course of oral paracetamol or placebo. Cardiac ultrasounds were used to document haemodynamic parameters. The primary outcome analysed was ductal closure by 48 h after treatment completion. Secondary outcomes included reduction in ductal diameter >25% and safety.

resultsFifty-five infants were enrolled, of whom 27 received paracetamol and 28 placebo. Eighty percent had received previous non-steroidal anti-inflammatory drug. Mean postnatal age was 25 days. Four of the 27 ducts treated with paracetamol closed vs. 0/28 treated with placebo (p = 0.05). An additional 13/27 given  paracetamol vs. 7/28 given placebo showed significant constriction (p = 0.008). No adverse effects were observed .

conclusionsThere was some evidence of increased closure with oral paracetamol at postnatal age >2 weeks; however, the overall efficacy was not high.

Indexed as

AcetaminophenDuctus Arteriosus, PatentAdministration, OralAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodFemaleGestational AgeHemodynamicsHumansInfant, NewbornInfant, PrematureIntensive Care, NeonatalMalePilot ProjectsTreatment OutcomeAcetaminophenAnti-Inflammatory Agents, Non-Steroidal

Identifiers

PMID30323322
OpenAlexW2898032207

What OpenQuestion holds

Textmetadata
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.