Persistent Pulmonary Hypertension of Newborn (PPHN) Clinical Trial
Official title:
Milrinone Pharmacokinetics and Pharmacodynamics in Newborns With Persistent Pulmonary Hypertension of the Newborn - a Pilot Study to Enable a Randomized Trial of Intervention
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).
Persistent pulmonary hypertension of the newborn (PPHN) is a condition in which the
pulmonary vasculature fails to relax after birth resulting in severe hypoxemia. This
condition has a high rate of mortality and morbidity. The current standard of care is
treatment with inhaled nitric oxide (iNO). However, for many babies this treatment does not
provide sufficient improvement in oxygenation.
In this study, subjects already receiving nitric oxide will be randomized to one of two
dosing regimens of milrinone. They will receive milrinone IV for 24 hours and will be
monitored for 24 hours afterwards. During this time, milrinone assays will be performed by
blood sampling. Echocardiograms will also be performed to explore the pharmacodynamics of
milrinone. Safety monitoring will be performed.
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment