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Clinical trialNCT06153459RecruitingInterventional

Cord Clamping Among Neonates With Congenital Heart Disease

SponsorCarl Backes, MDEnrollment500Congenital Heart Disease (CHD)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD). The main questions it aims to answer are: * Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) after birth lead to better health outcomes? * Does DCC-120 seconds or DCC-30 seconds after birth lead to better neuromotor outcomes at 22-26 months of infant age (postnatal)? Participants will be asked to do the following: * Participate in either DCC-120 or DCC-30 at birth (randomized assignment). * Complete General Movements Assessment (GMA) at 3-4 months of infant age (postnatal), complete questionnaires / surveys at this time. * Complete questionnaires / surveys at 9-12 months of infant age (postnatal). * Complete Hammersmith Infant Neurological Examination (HINE), Developmental Assessment of Young Children 2 Edition (DAYC-2), and questionnaires / surveys at 22-26 months of infant age (postnatal). * Permit data collection from electronic medical records for both the mother and infant study participants. Investigators will compare DCC-120 vs. DCC-30 to see which approach is more beneficial to both the mother and baby with CHD.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Stollery Children'S Hospital, University of Alberta

    Edmonton, Alberta, Canada

    Brenda Law, MD
    Recruiting
  • Iwk Health Centre

    Halifax, Nova Scotia, Canada

    Walid El-Naggar, MD
    Recruiting
  • the Hospital for Sick Children

    Toronto, Ontario, Canada

    Michael Seed, MBBS
    Not, yet, recruiting
United States
  • Children'S of Alabama

    Birmingham, Alabama, United States

    Andrea Kane, MD
    Recruiting
  • Cedars-Sinai Medical Center

    Los Angeles, California, United States

    Ruchira Garg, MD
    Recruiting
  • Children'S Hospital of Orange County

    Orange, California, United States

    Not, yet, recruiting
  • Lucile Packard Children'S Hospital Stanford

    Palo Alto, California, United States

    Not, yet, recruiting
  • Sharp Mary Birch Hospital for Woman and Newborns

    San Diego, California, United States

    Anup Katheria, MDJenny Koo, MD
    Recruiting
  • Uf Health Shands Children'S Hospital

    Gainesville, Florida, United States

    Jennifer Co-Vu, MD
    Recruiting
  • Johns Hopkins Children'S Center

    Baltimore, Maryland, United States

    Victoria Surma, MD
    Recruiting
  • Children'S of Mississippi

    Jackson, Mississippi, United States

    Simon Karam, MD
    Recruiting
  • the Children'S Mercy Hospital

    Kansas City, Missouri, United States

    John Daniel, MD
    Recruiting
  • Ssm Health Cardinal Glennon Children'S Hospital

    St Louis, Missouri, United States

    Justin Josephsen, MD
    Recruiting
  • Duke Children'S Hospital & Health Center

    Durham, North Carolina, United States

    Kevin Hill, MD
    Recruiting
  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

    Carl Backes, MD
    Recruiting
  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Elizabeth Foglia, MD
    Recruiting
  • Medical University of South Carolina

    Columbia, South Carolina, United States

    Sinai Zyblewski, MD
    Recruiting
  • Monroe Carell Jr. Children'S Hospital at Vanderbilt

    Nashville, Tennessee, United States

    Prince Kannankeril, MD
    Recruiting
  • Texas Children'S Hospital

    Houston, Texas, United States

    Nathan Sundgren, MD, PhD
    Recruiting
  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, United States

    J.B. Cantey, MD
    Recruiting
  • Primary Children'S Hospital

    Salt Lake City, Utah, United States

    Ryan Carpenter, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
19 Dec 2023
Primary completion
31 Oct 2028
Completion
31 Dec 2030
Last update posted
12 Aug 2026
Registered enrollment
500
Registry id
NCT06153459

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.