Evidence map›Paper›PMID 39053961›Full record

ArticleBMJ open2024

Selective early medical treatment of the patent ductus arteriosus in extremely low gestational age infants: a pilot randomised controlled trial protocol (SMART-PDA).

Souvik Mitra, Audrey Hébert, Michael Castaldo, Tim Disher, Walid El-Naggar, Santokh Dhillon, Ziad Alhassen, Jenny Koo, Anup C Katheria, Abbas Hyderi and 10 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05011149 (Selective Early Medical Treatment of the Patent Ductus Arteriosus in Extremely Low Gestational Age Infants), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT05011149 phase3unknown statusnot on this map

Selective Early Medical Treatment of the Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot Randomized Controlled Trial

TypeinterventionalSponsorIWK Health CentreRan2022 to 2024Enrolled100ConditionsPatent Ductus Arteriosus After Premature BirthArmsIbuprofen
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Beyond diameter: redefining echocardiography criteria in trials of early PDA therapy.Journal of perinatology : official journal of the California Perinatal Association · 2026
    Article
  6. Article
  7. Response to the letter.Journal of perinatology : official journal of the California Perinatal Association · 2025
    Article
  8. Review
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

20 authors.

Souvik MitraDepartment of Pediatrics, Faculty of Medicine, The University of British Columbia & BC Women's Hospital, Vancouver, British Columbia, Canada souvik.mitra@cw.bc.ca.ORCID 0000-0002-7477-7264
Audrey HébertDivision of Neonatology, CHU de Québec, Université Laval, Quebec City, Quebec, Canada.
Michael CastaldoDepartment of Pediatrics, Faculty of Medicine, The University of British Columbia & BC Women's Hospital, Vancouver, British Columbia, Canada.
Tim DisherEversana Inc, Sydney, Nova Scotia, Canada.
Walid El-NaggarDivision of Neonatal Perinatal Medicine, IWK Health, Halifax, Nova Scotia, Canada.
Santokh DhillonDepartment of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.
Ziad AlhassenDepartment of Pediatrics, CHOC Children's, Orange County, California, USA.
Jenny KooNeonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA.ORCID 0000-0002-0925-7115
Anup C KatheriaNeonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA.ORCID 0000-0001-9352-0934
Abbas HyderiDepartment of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
Kumar KumaranDepartment of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
Marjorie MakoniDepartment of Pediatrics, University of Oklahoma, Oklahoma City, Oklahoma, USA.
Dany E WeiszNewborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Amish JainDepartment of Pediatrics, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-1413-2966
Fabiana BacchiniCanadian Premature Babies' Foundation, Toronto, Ontario, Canada.
Austin CameronDivision of Neonatal Perinatal Medicine, IWK Health, Halifax, Nova Scotia, Canada.
Tara HatfieldDivision of Neonatal Perinatal Medicine, IWK Health, Halifax, Nova Scotia, Canada.
Jon DorlingDivision of Neonatal Perinatal Medicine, IWK Health, Halifax, Nova Scotia, Canada.
Patrick J McNamaraDepartment of Pediatrics, The University of Iowa Stead Family Children's Hospital, Iowa City, Iowa, USA.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0003-0355-9734

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatent ductus arteriosus (PDA) is the most common cardiovascular problem that develops in extremely preterm infants and is associated with poor clinical outcomes. Uncertainty exists on whether early pharmacotherapeutic treatment of a clinically symptomatic and echocardiography-confirmed haemodynamically significant PDA in extremely preterm infants improves outcomes. Given the wide variation in the approach to PDA treatment in this gestational age (GA) group, a randomised trial design is essential to address the question. Before embarking on a large RCT in this vulnerable population, it is important to establish the feasibility of such a trial. METHODS AND ANALYSIS: ETHICS AND DISSEMINATION: The study has been approved by the IWK Research Ethics Board (#1027298) and six additional participating sites. On the completion of the study, results will be presented at national and international meetings, published in peer-reviewed journals and incorporated into existing systematic reviews. TRIAL REGISTRATION NUMBER: NCT05011149 (WHO Trial Registration Data Set in Appendix A). PROTOCOL VERSION: Ver 7.2 (dated July 19, 2023).

Indexed as

Ductus Arteriosus, PatentInfant, Extremely PrematureInfant, Small for Gestational AgeRandomized Controlled Trials as TopicEchocardiographyFemaleGestational AgeHumansInfant, NewbornMaleMulticenter Studies as TopicPilot ProjectsNeonatal intensive & critical careNEONATOLOGYRandomized Controlled Trial

Identifiers

PMID39053961
PMCPMC11284877

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.