Cord Clamping Among Neonates With Congenital Heart Disease

Recruiting now · Not applicable

Conditions studied: Congenital Heart Disease (CHD)

In brief

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.

Key facts

Study ID

NCT06153459

Run by

Carl Backes, MD

People needed

500

Starts

2023-12-19

Expected to finish

2030-12-01

Last updated by the study team

2025-08-05

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)
• Stollery Children's Hospital, University of Alberta — Edmonton, Alberta, Canada (enrolling)
• IWK Health Centre — Halifax, Nova Scotia, Canada (enrolling)
• Sharp Mary Birch Hospital for Woman and Newborns — San Diego, California, United States (enrolling)
• UF Health Shands Children's Hospital — Gainesville, Florida, United States (enrolling)
• Johns Hopkins Children's Center — Baltimore, Maryland, United States (enrolling)
• Children's of Mississippi — Jackson, Mississippi, United States (enrolling)
• The Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
• SSM Health Cardinal Glennon Children's Hospital — St Louis, Missouri, United States (enrolling)
• Duke Children's Hospital & Health Center — Durham, North Carolina, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Columbia, South Carolina, United States (enrolling)
• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (enrolling)
• Texas Children's Hospital — Houston, Texas, United States (enrolling)
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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