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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Persistent Fetal Circulation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High 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.

Group Type EXPERIMENTAL

Milrinone Lactate

Intervention Type DRUG

Milrinone lactate will be given first as an IV bolus over one hour at the assigned dose level, followed by a 24 hour IV infusion at the assigned dose level.

Low Dose Milrinone

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.

Group Type EXPERIMENTAL

Milrinone Lactate

Intervention Type DRUG

Milrinone lactate will be given first as an IV bolus over one hour at the assigned dose level, followed by a 24 hour IV infusion at the assigned dose level.

Interventions

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Milrinone Lactate

Milrinone lactate will be given first as an IV bolus over one hour at the assigned dose level, followed by a 24 hour IV infusion at the assigned dose level.

Intervention Type DRUG

Other Intervention Names

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Milrinone

Eligibility Criteria

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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

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No