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.
Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT
At a glance
Conditions
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Withdrawn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.
Study leadership
- Souvik Mitra, MD, MSc · PRINCIPAL_INVESTIGATOR · Dalhousie University & IWK Health
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Proportion of eligible infants recruited during the study period7 days postnatal age
- Proportion of randomized infants with no reported protocol deviations7 days postnatal age