Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Description

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

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Study Overview

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Study Details

Study overview

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.

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Condition
Post-ligation Cardiac Syndrome
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama - Birmingham, Birmingham, Alabama, United States, 35249

Orange

Children's Hospital of Orange County, Orange, California, United States, 92868

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

San Diego

Sharp Mary Birch Hospital for Women & Newborns, San Diego, California, United States, 92123

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Chicago

Northwestern Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Jackson

University of Mississippi Medical Center, Jackson, Mississippi, United States, 39216

Albuquerque

University of New Mexico, Albuquerque, New Mexico, United States, 87131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

to 3 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NICHD Neonatal Research Network,

Study Record Dates

2029-06-30