Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Launched by NICHD NEONATAL RESEARCH NETWORK · Nov 5, 2024

Keywords

ClinConnect Summary

The Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial is a study designed to see if a medication called milrinone can help improve heart function in infants after a procedure to close a heart defect known as a patent ductus arteriosus (PDA). The main goals are to find out if milrinone can reduce the chances of death or serious complications within a week after the procedure and to check how it affects survival and brain development over the next two years.

To participate in this trial, infants must be born very early (at or before 27 weeks) and be less than three months old at the time of treatment. They also need to be receiving help with breathing and have a significant PDA that requires closure. Unfortunately, babies with certain heart defects or major health issues won't be eligible. If your child qualifies and you choose to participate, they will receive either milrinone or standard treatment, and their progress will be closely monitored by the medical team. This trial is an important step in finding better ways to support the health of vulnerable infants after heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Gestational age at birth ≤27 weeks (and 6 days) and postnatal age \< 3 months at intervention
• • Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula)
• • Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention
• • Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance.
• Exclusion Criteria:
• • Any major congenital malformation
• • Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (\<3mm) atrial septal defect)
• • Acute renal failure defined by urine output \< 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours.
• • Systemic administration of vasodilator/inodilator agents
• • Prior history of arrhythmia