Management of the PDA Trial
Purpose
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
Conditions
- Infant, Premature
- Patent Ductus Arteriosus
- Infant, Newborn, Diseases
- Patent Ductus Arteriosus After Premature Birth
Eligibility
- Eligible Ages
- Between 48 Hours and 21 Days
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Postnatal age 48 hours -21 days - Infant 22 0/7 to 28 6/7 weeks gestation at birth - sPDA, as defined as: 1. Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram 2. Mild or Moderate Clinical Criteria with Large PDA on echocardiogram
Exclusion Criteria
- Cardiopulmonary compromise - Known congenital heart disease (besides atrial septal defect or ventricular septal defect) - Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation) - Any condition which, in the opinion of the investigator, would preclude enrollment
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Active Treatment Group |
Infants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other. |
|
|
Active Comparator Expectant Management Group |
Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs. |
|
Recruiting Locations
Birmingham, Alabama 35233
Waldemar A. Carlo, MD
More Details
- Status
- Recruiting
- Sponsor
- NICHD Neonatal Research Network
Detailed Description
This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a symptomatic patent ductus arteriosus (sPDA) to expectant management. We hypothesize in premature infants with a sPDA, expectant management reduces the incidence proportion of death or BPD by 10% (from 50% to 40%) when compared to active treatment. Participants with a sPDA allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). The decision to ligate will be left to the clinical team. Participants with a sPDA allocated to the expectant management arm will receive supportive care at the clinical team's discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. The decision to ligate will be left to the clinical team. The primary endpoint for the study will be death or BPD (as assessed by the physiologic definition) at 36 weeks postmenstrual age (PMA).