Management of the PDA Trial

Running, not enrolling · Phase 3

Conditions studied: Infant, Premature, Patent Ductus Arteriosus, Infant, Newborn, Diseases, Patent Ductus Arteriosus After Premature Birth

In brief

Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.

Key facts

Study ID

NCT03456336

Run by

NICHD Neonatal Research Network

People needed

482

Starts

2019-02-22

Expected to finish

2027-05-30

Last updated by the study team

2026-05-12

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Brown University - Women and Infants Hospital of Rhode Island — Providence, Rhode Island, 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

Full record on ClinicalTrials.gov

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