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

NCT01088997 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-07-12

Study results available
· View outcomes & findings →

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).

Conditions

  • Persistent Fetal Circulation Syndrome

Interventions

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Haresh Kirpalani, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-02-28
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01088997 on ClinicalTrials.gov