Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
NICHD Neonatal Research Network
316 participants
Jun 13, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria5
- 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
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Interventions
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).
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06679855