Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT (SMART-PDA)
Patent Ductus Arteriosus After Premature Birth
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus After Premature Birth focused on measuring extremely preterm infant, early medical treatment, randomized controlled trial
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
Sites / Locations
- Children's Hospital of Orange County
- Sharp Mary Birch Hospital for Women & Newborns
- Stollery Children's Hospital
- British Columbia Women's Hospital
- IWK Health CenterRecruiting
- Mount Sinai Hospital
- Sunnybrook Health Sciences Centre
- Centre Hospitalier Universitaire de Quebec
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Selective early medical treatment (SMART) strategy
Early conservative management strategy
Infants who are randomized to experimental group will follow the SMART treatment protocol, which includes echocardiographic screening every 72 hours to categorize PDA disease severity by combining clinical and echocardiographic features. At any evaluation if patients are found to have a "severe PDA" on echocardiography, irrespective of clinical symptoms, or a "moderate PDA" on echocardiography with at least moderate clinical illness, they will receive pharmacotherapy aimed at PDA closure (The PDA severity has been divided into mild, moderate or severe based on pre-defined clinical and echocardiographic criteria).
Infants randomized to this arm will not undergo any further echocardiographic assessment or pharmacological treatment of the PDA regardless of the clinical signs. If the infant gets an echocardiographic assessment for a reason different than PDA assessment (such as hypotension or oxygenation failure) and a PDA is incidentally noted that fits the treatment criteria, the infant will not be initiated on pharmacotherapy. After 7 days of age, decision on PDA assessment and treatment will be at the discretion of the treating physician.