Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
ConditionPost-ligation Cardiac Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 3
SponsorNICHD Neonatal Research Network
About this trial
The goal of this Phase 3, randomized, masked clinical trial is to is to find out whether milrinone, when given to infants after PDA closure, will help the heart work better by supplying oxygen to the lungs and tissues.
The main questions it aims to answer are:
1. to determine if milrinone decreases the risk of death or PLCS within 7 days of the procedure, compared to standard treatment; and 2. to determine the effects of milrinone on two-year survival and neurodevelopmental outcome.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Milrinone infusion
- Placebo infusion
Treatment groups
316 Participants
are divided into 2 treatment groupsSponsors and collaborators
NICHD Neonatal Research Network
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov