Milrinone in Congenital Diaphragmatic Hernia
Public ClinicalTrials.gov record NCT02951130. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02951130
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Hours to 168 Hours
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 24, 2017 (Actual)
- Primary completion
- Sep 30, 2024 (Actual)
- Completion
- May 19, 2025 (Actual)
- Last update posted
- Nov 6, 2025
2017 – 2025
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Children's Mercy | Kansas City | Missouri | 64108 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| Columbia University | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| RTI International | Durham | North Carolina | 27709 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | — |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02951130, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02951130 live on ClinicalTrials.gov.