Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants

This study is looking at the best way to treat a common heart condition called Patent Ductus Arteriosus (PDA) in very premature babies. PDA is when a blood vessel that's open during pregnancy doesn't close after birth, which can lead to health problems. Researchers are testing if giving ibuprofen early to these babies, when indicated by an echocardiogram (a heart ultrasound), helps. Ibuprofen is a common medication used for PDA, but it can also have side effects in very premature infants. This study aims to enroll 100 infants who are born before 26 weeks of pregnancy and are up to 72 hours old. The main goals are to see how many eligible infants join the study and how many follow the study plan without issues. The study's current status is unclear.

Study design
This is a pilot randomized controlled trial, meaning participants are assigned by chance to different treatment groups. The study plans to enroll 100 infants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 7 days postnatal age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05011149

Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT

UNKNOWN
PHASE3Up to 72InterventionalTreatment
IWK Health Centre
~100 participants
Updated 2024-06-21 on ClinicalTrials.gov
What's tested:Ibuprofen

At a glance

Recruiting sites
6 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of eligible infants recruited during the study period
Measured over 7 days postnatal age
+1 more outcome measured
Patent Ductus Arteriosus After Premature Birth

NCT05011149

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • British Columbia Women's Hospital

    Vancouver, British Columbia, Canadano site contact published

    Recruiting

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, Canadano site contact published

    Recruiting

  • Children's Hospital of Orange County

    Orange, Californiano site contact published

    Recruiting

  • IWK Health Center

    Halifax, Nova Scotia, Canadano site contact published

    Recruiting

  • OU College of Medicine, University of Oklahoma

    Oklahoma City, Oklahomano site contact published

    Recruiting

  • Stollery Children's Hospital

    Edmonton, Alberta, Canadano site contact published

    Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario, Canadano site contact published

    Withdrawn

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, Californiano site contact published

    Terminated

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Souvik Mitra, MD, MSc · PRINCIPAL_INVESTIGATOR · Dalhousie University & IWK Health

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Eligibility criteria

Inclusion

Preterm infants less than 26 completed weeks (i.e., up to and including 25 weeks and 6 days) of gestation

Exclusion

no PDA on initial screening echocardiography
congenital heart disease (excluding patent foramen ovale, atrial septal defect or ventricular septal defect with a defect size less than 2mm)
other major congenital anomaly
decision to withhold/withdraw care
  • Proportion of eligible infants recruited during the study period7 days postnatal age
  • Proportion of randomized infants with no reported protocol deviations7 days postnatal age