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Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
Sponsor: NICHD Neonatal Research Network
Summary
The goal of this Phase 3, randomized, masked clinical trial is to is to find out whether milrinone, when given to infants after PDA closure, will help the heart work better by supplying oxygen to the lungs and tissues. The main questions it aims to answer are: 1. to determine if milrinone decreases the risk of death or PLCS within 7 days of the procedure, compared to standard treatment; and 2. to determine the effects of milrinone on two-year survival and neurodevelopmental outcome.
Key Details
Gender
All
Age Range
Any - 3 Months
Study Type
INTERVENTIONAL
Enrollment
316
Start Date
2025-06-13
Completion Date
2029-06-30
Last Updated
2025-06-15
Healthy Volunteers
No
Conditions
Interventions
Milrinone infusion
An intravenous (iv) infusion of milrinone will be administered at an initial dose of 0.33 mcg/kg/min and accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes).
Placebo infusion
An iv infusion of placebo (0.9% saline) of equivalent volume will be administered. The infusion will be accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes) to ensure blinding is maintained.
Locations (19)
University of Alabama - Birmingham
Birmingham, Alabama, United States
Children's Hospital of Orange County
Orange, California, 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
Boston Children's Hospital
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of New Mexico
Albuquerque, New Mexico, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Texas at Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States