RECRUITING

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

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Conditions

Post-ligation Cardiac Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Quick Facts

Study Start:2025-05-14
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06679855

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.

Ages Eligible for Study:Not specified to 3 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Gestational age at birth ≤27 weeks (and 6 days) and postnatal age \< 3 months at intervention
  2. * Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula)
  3. * Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention
  4. * 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.
  1. * Any major congenital malformation
  2. * Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (\<3mm) atrial septal defect)
  3. * 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.
  4. * Systemic administration of vasodilator/inodilator agents
  5. * Prior history of arrhythmia

Contacts and Locations

Study Contact

Patrick J McNamara
CONTACT
319-467-7435
patrick-mcnamara@uiowa.edu
Valerie Chock
CONTACT
650-723-5711
vchock@stanford.edu

Study Locations (Sites)

University of Alabama - Birmingham
Birmingham, Alabama, 35249
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Stanford University
Palo Alto, California, 94304
United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
United States
Emory University
Atlanta, Georgia, 30322
United States
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
Duke University
Durham, North Carolina, 27705
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Case Western Reserve University
Cleveland, Ohio, 44106
United States
University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
University of Texas at Houston
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: NICHD Neonatal Research Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-14
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2025-05-14
Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Post-ligation Cardiac Syndrome