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Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

RecruitingPhase 3

Sponsor: NICHD Neonatal Research Network

Conditions: Post-ligation Cardiac Syndrome

Interventions: Milrinone infusion, Placebo infusion

Countries: United States

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 overview

Sex: ALL

Age: — to 3 Months

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (19)

Birmingham, Alabama, United States
Orange, California, United States
Palo Alto, California, United States
San Diego, California, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
Jackson, Mississippi, United States
Albuquerque, New Mexico, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States