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Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

RecruitingPhase 3

Who can join

3 Months · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: NICHD Neonatal Research Network · Participants: 316 · Started: Jun 13, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06679855

Locations in the U.S.

AlabamaUniversity of Alabama - Birmingham, Birmingham (Not yet recruiting)
CaliforniaChildren's Hospital of Orange County, Orange (Not yet recruiting)
Stanford University, Palo Alto
Sharp Mary Birch Hospital for Women & Newborns, San Diego (Not yet recruiting)
GeorgiaEmory University, Atlanta
IllinoisNorthwestern Lurie Children's Hospital of Chicago, Chicago
IowaUniversity of Iowa, Iowa City
MassachusettsBoston Children's Hospital, Boston
MississippiUniversity of Mississippi Medical Center, Jackson (Not yet recruiting)
New MexicoUniversity of New Mexico, Albuquerque
North CarolinaDuke University, Durham
OhioCincinnati Children's Hospital Medical Center, Cincinnati
Case Western Reserve University, Cleveland
OklahomaUniversity of Oklahoma Health Sciences, Oklahoma City
PennsylvaniaUniversity of Pennsylvania, Philadelphia
TennesseeLe Bonheur Children's Hospital, Memphis
TexasUniversity of Texas Southwestern, Dallas
University of Texas at Houston, Houston
UtahUniversity of Utah, Salt Lake City

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.