Actively Recruiting
Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
Led by NICHD Neonatal Research Network · Updated on 2026-04-20
316
Participants Needed
19
Research Sites
211 weeks
Total Duration
On this page
Sponsors
N
NICHD Neonatal Research Network
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age at birth 6427 weeks (and 6 days) and postnatal age < 3 months at intervention
- Receiving invasive or non-invasive positive pressure respiratory support (not including low flow nasal cannula)
- Hemodynamically significant PDA with minimum transductal diameter 641.0 mm within 2 days of intervention
- Clinical team decision to proceed with PDA closure by surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features
You will not qualify if you...
- Any major congenital malformation
- Congenital heart disease except small (641mm) 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 within prior 72 hours
- Systemic administration of vasodilator/inodilator agents
- Prior history of arrhythmia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35249
Not Yet Recruiting
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Not Yet Recruiting
3
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
4
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
Not Yet Recruiting
5
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
7
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Not Yet Recruiting
10
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
11
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
12
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
13
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
14
University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
15
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Actively Recruiting
17
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
18
University of Texas at Houston
Houston, Texas, United States, 77030
Actively Recruiting
19
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
Research Team
P
Patrick J McNamara
CONTACT
V
Valerie Chock
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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