Milrinone in Congenital Diaphragmatic HerniaResearch Question:
Is the drug Milrinone safe and effective at improving oxygen levels in infants with
congenital diaphragmatic hernia (a hole in the diaphragm)?
Basic Study Information
Purpose:Location: University of Rochester
Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia
persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory
failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant
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
prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic
contraction and diastolic relaxation respectively) with pulmonary vasodilator properties
has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used
the management of CDH although no randomized trials have been performed to test its
Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND)
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
CDH will be randomized to receive milrinone or placebo to establish safety of this
in CDH and test its efficacy in improving oxygenation.
Study Contact InformationStudy Coordinator: Carl T D'Angio, MD
Phone: (716) 878-7673
Additional Study Details
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