Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn
Persistent Fetal Circulation Syndrome
About this trial
This is an interventional treatment trial for Persistent Fetal Circulation Syndrome focused on measuring Persistent pulmonary hypertension of newborn, PPHN, Persistent pulmonary hypertension, Pulmonary hypertension, Pulmonary hypertension of newborn
Eligibility Criteria
Inclusion Criteria:
- Gestational age > 34 weeks
- Post-natal age < 10 days
- Hypoxemia defined by: Oxygenation Index (OI) >15 (Mean Airway Pressure x Fraction of Inspired Oxygen (FiO2) x 100 /PaO2) as drawn from two post-ductal arterial blood gas samples (in-dwelling arterial catheter) taken at least 15 minutes apart. OR mechanically ventilated and with >75% FiO2 for >6 hours while on iNO
- Absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
- An in-dwelling arterial catheter to facilitate painless sampling
- Currently on iNO or plan to start iNO before enrollment
Exclusion Criteria:
- Lethal non-cardiac congenital anomalies including diaphragmatic hernia
- Clinically apparent bleeding; thrombocytopenia <30,000 or other laboratory evidence of coagulopathy
- Currently on extracorporeal membrane oxygenation (ECMO)or plan to initiate ECMO within 2 hours of enrollment
Sites / Locations
- Children's Hospital of Michigan/Hutzel Women's Hospital
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
High Dose Milrinone
Low Dose Milrinone
Subjects will receive a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours. After completion of infusion, subjects will be monitored for an additional 24 hours.
Subjects will receive a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours. After completion of infusion, subjects will be monitored for an additional 24 hours.