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NCT02951130 · ClinicalTrials.gov registry record · Phase 2
Milrinone in Congenital Diaphragmatic Hernia
A Phase 2 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT02951130 is a Phase 2 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 66 participants.
The verdict
NCT02951130, a Phase 2 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction. In patients with CDH, left ventricular dysfunction, either caused by right ventricular overload or a relative underdevelopment of the left ventricle, is associated with poor prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone. In the recently published VICI trial, 84% of patients with CDH received a vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation.
Interventions
- DRUG Milrinone
- DRUG Placebo (5% Dextrose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2025-05-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02951130
The ClinicalTrials.gov registry entry for NCT02951130 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Milrinone is the first listed.
NCT02951130 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02951130 about?
NCT02951130 is a clinical study titled "Milrinone in Congenital Diaphragmatic Hernia". Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator th...
What is the current status of trial NCT02951130?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2017-10-24. Estimated completion is 2025-05-19.
What interventions are being tested in trial NCT02951130?
The interventions under investigation include: Milrinone (DRUG), Placebo (5% Dextrose) (DRUG).
Who is sponsoring clinical trial NCT02951130?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
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