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

Stopped early · Not applicable

Conditions studied: Persistent Fetal Circulation Syndrome

In brief

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).

Key facts

Study ID

NCT01088997

Run by

Children's Hospital of Philadelphia

People needed

12

Starts

2010-06-01

Expected to finish

2015-05-01

Last updated by the study team

2016-07-12

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Michigan/Hutzel Women's Hospital — Detroit, Michigan, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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