NICHD Neonatal Research Network
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.
Researchers will compare milrinone to a placebo saline solution to see if it helps the heart work better by supplying oxygen to the lungs and tissues. After randomization the following will happen in both the control and treatment groups: * Infant will start receiving either a low dose (0.33 μg/kg/min) of milrinone in the treatment group, OR saline solution in the control group through an intravenous (IV) line. The study drug will be started within 2 hours of the PDA closure procedure. * For the first 2 to 4 hours, the study team will monitor very closely to see if there are any major side e…
Inclusion Criteria: * 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 Criteria: * Any major congenital malformation * Congenital hear…
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.