Status:
ACTIVE_NOT_RECRUITING
Management of the PDA Trial
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant, Premature
Patent Ductus Arteriosus
Eligibility:
All Genders
48-21 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
836 Patients enrolled
Trial Details
Trial ID
NCT03456336
Start Date
February 22 2019
End Date
May 30 2027
Last Update
September 15 2025
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
4
Emory University
Atlanta, Georgia, United States, 30303