Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Post-ligation Cardiac Syndrome

In brief

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 facts

Study ID

NCT06679855

Run by

NICHD Neonatal Research Network

People needed

316

Starts

2025-06-13

Expected to finish

2029-06-30

Last updated by the study team

2026-07-01

Who can join

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

You may qualify if…

• Gestational age at birth ≤27 weeks (and 6 days) and postnatal age < 3 months at intervention
• Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula)
• Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention
• Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance.

You may not qualify if…

• Any major congenital malformation
• Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (<3mm) atrial septal defect)
• Acute renal failure defined by urine output < 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours.
• Systemic administration of vasodilator/inodilator agents
• Prior history of arrhythmia

Where it is running

• University of Utah — Salt Lake City, Utah, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States (enrolling)
• University of Texas Southwestern — Dallas, Texas, United States (enrolling)
• University of Texas at Houston — Houston, Texas, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Northwestern Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Case Western Reserve University — Cleveland, Ohio, United States (enrolling)
• University of Oklahoma Health Sciences — Oklahoma City, Oklahoma, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States
• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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