Management of the PDA Trial
- Conditions
- Patent Ductus ArteriosusInfant, PrematureInfant, Newborn, DiseasesPatent Ductus Arteriosus After Premature Birth
- Interventions
- Other: Active TreatmentOther: Expectant Management
- Registration Number
- NCT03456336
- Lead Sponsor
- NICHD Neonatal Research Network
- Brief Summary
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 836
-
Postnatal age 48 hours -21 days
-
Infant 22 0/7 to 28 6/7 weeks gestation at birth
-
sPDA, as defined as:
- Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram
- Mild or Moderate Clinical Criteria with Large PDA on echocardiogram
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Treatment Group Active Treatment 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. Expectant Management Group Expectant Management Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.
- Primary Outcome Measures
Name Time Method Death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA birth to 36 week postmenstrual age Death or BPD. BPD will be defined by the physiologic definition.
- Secondary Outcome Measures
Name Time Method Mortality at 36 weeks PMA birth to 36 week postmenstrual age mortality assessed at 36 week postmenstrual age
Necrotizing Enterocolitis (NEC) at 36 weeks PMA birth to 36 weeks post menstrual age Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB
Weight at 36 weeks PMA birth to 36 weeks post menstrual age Weight assessed at 36 weeks post menstrual age
Receipt of therapies designed to close the PDA birth to 120 days Defined as ligation or cardiac catheterization
Mortality before discharge birth to 120 days of life mortality assessed prior to hospital discharge
Bronchopulmonary dysplasia - NIH Consensus Definition birth to 36 week postmenstrual age BPD defined by the NIH consensus definition of moderate or severe
Height at 36 weeks PMA birth to 36 weeks post menstrual age Height assessed at 36 weeks post menstrual age
Bronchopulmonary dysplasia - Physiological Test birth to 36 week postmenstrual age BPD defined by the physiologic test of oxygen therapy
Retinopathy of Prematurity at 36 weeks PMA birth to 36 weeks post menstrual age Stage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug
Head Circumference at 36 weeks PMA birth to 36 weeks post menstrual age Head Circumference assessed at 36 weeks post menstrual age
Trial Locations
- Locations (19)
Brown University - Women and Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford University
🇺🇸Palo Alto, California, United States
Sharp Mary Birch Hospital for Women & Newborns
🇺🇸San Diego, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Mississippi Medical Center - Children's of Mississippi
🇺🇸Jackson, Mississippi, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Rochester
🇺🇸Rochester, New York, United States
RTI International
🇺🇸Durham, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Research Institute at Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States