Milrinone in Congenital Diaphragmatic Hernia

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.

Conditions

• Congenital Diaphragmatic Hernia
• Persistent Pulmonary Hypertension of the Newborn
• Hypoxemic Respiratory Failure
• Pulmonary Hypoplasia

Interventions

DRUG

Milrinone

The study intervention is an intravenous infusion of milrinone or placebo

DRUG

Placebo (5% Dextrose)

The study intervention is an intravenous infusion of milrinone or placebo

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Satyan Lakshminrusimha, M.D. · University of California, Davis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

0 Hours

Max Age

168 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-24

Primary Completion

2024-09-30

Completion

2025-05-19

FDA Drug

Yes

Countries

• United States

Study Locations