Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to determine a safe dose of milrinone to use in a larger study of babies with persistent pulmonary hypertension of the newborn (PPHN).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: American Medical Association; Bedford Pharmaceuticals; Thrasher Research Fund; University of Pennsylvania
• Treatments: Milrinone

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