Recruiting

Phase 3

MilrinoneMilrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Sponsor:

NICHD Neonatal Research Network

Code:

NCT06679855

Conditions

Post-ligation Cardiac Syndrome

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Milrinone infusion

Placebo infusion

Study Details

Brief summary:

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.

Conditions

Post-ligation Cardiac Syndrome

Study ID

NCT06679855

Start date

Jun 13, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

316 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

An iv infusion of placebo (0.9% saline) of equivalent volume will be administered. The infusion will be accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes) to ensure blinding is maintained.

active comparator: Milrinone

An intravenous (iv) infusion of milrinone will be administered at an initial dose of 0.33 mcg/kg/min and accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes).

Interventions

Milrinone infusion

An intravenous (iv) infusion of milrinone will be administered at an initial dose of 0.33 mcg/kg/min and accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes).

Placebo infusion

Primary outcome measure

Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure [ Time Frame: Onset within 48 hours but may last up to 7 days ]

Central Contacts and Locations

Central contacts

Patrick J McNamara

319-467-7435 patrick-mcnamara@uiowa.edu

Valerie Chock

650-723-5711 vchock@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Valerie Chock

650-723-5711 vchock@stanford.edu

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Ravi M Patel

404-727-5905 rmpatel@emory.edu

Northwestern Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Aaron Hamvas

312-227-4190 ahamvas@luriechildrens.org

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Tarah Colaizy

319-356-3508 tarah-colaizy@uiowa.edu

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Philip Levy

617-919-2358 Philip.Levy@childrens.harvard.edu

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Janell Fuller

505-272-6409 jafuller@salud.unm.edu

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Michael Cotten

919-681-0630 michael.cotten@duke.edu

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Stephanie Merhar

513-803-5180 Stephanie.Merhar@cchmc.org

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Anna Maria Hibbs

216-844-3387 annamaria.hibbs@cwru.edu

University of Oklahoma Health Sciences

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Marjorie Makoni

405-271-5215 Marjorie-Makoni@ouhsc.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Sara DeMauro

215-590-3730 demauro@email.chop.edu

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Mark Weems

901-448-2262 mweems@uthsc.edu

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Myra H Wyckoff

214-590-4003 myra.wyckoff@utsouthwestern.edu

University of Texas at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Matthew Rysavy

713-500-6643 matthew.a.rysavy@uth.tmc.edu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Robin Ohls

801-213-1487 robin.ohls@hsc.utah.edu

More Information

Sponsor

NICHD Neonatal Research Network

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NICHD Neonatal Research Network on 2026-07-01.