Early treatment of heart condition in extremely preterm infants

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

This study is testing if giving ibuprofen early to extremely preterm infants with a heart condition called patent ductus arteriosus can help improve their health.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: N/A to 72 Hours
• Sex: All
• Sponsor: IWK Health Centre (other)
• Locations: 9 sites (Orange, California and 8 other locations)
• Trial ID: NCT05011149 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial investigates the effects of early medical treatment for patent ductus arteriosus (PDA) in extremely low gestational age infants, specifically those born before 26 weeks. The study aims to determine whether administering ibuprofen to treat symptomatic PDA can improve health outcomes in this vulnerable population. Given the high incidence of PDA in preterm infants and the potential risks associated with current treatment methods, this trial seeks to clarify the benefits and risks of early intervention. The research will involve multiple leading health institutions to ensure a robust analysis of the treatment's efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants born at less than 26 weeks of gestation who have been diagnosed with a patent ductus arteriosus.

Not a fit: Patients who do not have a patent ductus arteriosus or have significant congenital heart defects may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for extremely preterm infants with PDA, potentially reducing long-term health complications.

How similar studies have performed: While there is ongoing debate regarding the treatment of PDA in preterm infants, this specific approach using early ibuprofen treatment is novel and has not been extensively tested in this population.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Where this trial is running

Orange, California and 8 other locations

• Children's Hospital of Orange County — Orange, California, United States (RECRUITING)
• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States (TERMINATED)
• OU College of Medicine, University of Oklahoma — Oklahoma City, Oklahoma, United States (RECRUITING)
• Stollery Children's Hospital — Edmonton, Alberta, Canada (RECRUITING)
• British Columbia Women's Hospital — Vancouver, British Columbia, Canada (RECRUITING)
• IWK Health Center — Halifax, Nova Scotia, Canada (RECRUITING)
• Mount Sinai Hospital — Toronto, Ontario, Canada (WITHDRAWN)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (WITHDRAWN)
• Centre Hospitalier Universitaire de Quebec — Québec, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Souvik Mitra, MD, MSc — Dalhousie University & IWK Health
• Study coordinator: Souvik Mitra, MD, MSc

Conditions: Patent Ductus Arteriosus After Premature Birth, extremely preterm infant, early medical treatment, randomized controlled trial