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NCT01088997 · ClinicalTrials.gov registry record · NA
Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn
A NA study, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT01088997: Clinical Trial NA study, sponsored by Children's Hospital of Philadelphia.
NCT01088997 is a NA study that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01088997, a NA study, was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study 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).
Primary Outcome
The schedule of milrinone pharmacokinetic (PK) sampling varied by weight to minimize blood sampling. For babies weighing less than 3kg, samples were drawn at the end of the bolus, 15 minutes prior to the end of infusion (EOI) and 20 minutes, 1, 2, 6 and 12 hours after EOI. For babies weighing 3kg or more, samples were drawn at the end of the bolus, 6 hours after start of infusion, 15 minutes prior to the EOI and 30 minutes, 1, 3, 9 and 15 hours after EOI. Milrinone plasma concentrations were det
Interventions
- DRUG Milrinone Lactate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-06 |
| Est. Completion | 2015-05 |
| Phase | NA |
Why NCT01088997 stopped before completion
NCT01088997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Milrinone Lactate is the first listed.
NCT01088997 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01088997 about?
NCT01088997 is a clinical study titled "Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn". 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).
What is the current status of trial NCT01088997?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2010-06. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01088997?
The interventions under investigation include: Milrinone Lactate (DRUG).
Who is sponsoring clinical trial NCT01088997?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01088997's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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