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
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
- collaborator OTHER
-
Bedford Pharmaceuticals
collaborator INDUSTRY - collaborator OTHER
-
Thrasher Research Fund
collaborator OTHER -
Children's Hospital of Philadelphia
lead OTHER
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
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