Cord Clamping Among Neonates With Congenital Heart Disease
Start Date
12/19/2023
Completion Date
12/1/2030
Summary
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.
Detailed Description
* AIM 1: Test the hypothesis that, among neonates with prenatally diagnosed significant CHD (ranking of 3 - 6 on the Fetal Cardiovascular Disease Severity Score \[FCDSS\]), DCC-120 results in lower global rank score (GRS), indicative of better health outcomes, compared with DCC-30. * AIM 2: Test the hypothesis that, among neonates with prenatally diagnosed significant CHD (ranking from 3 - 6 on the Fetal Cardiovascular Disease Severity Score \[FCDSS\]), DCC-120 will result in better neuromotor outcomes at 22-26 months postnatal than DCC-30.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Umbilical Cord Clamping at ~30 seconds
Umbilical Cord Clamping at ~120 seconds
Umbilical Cord Milking
Conditions
Locations
Children's of Alabama
Birmingham, Alabama 35233
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Children's Hospital of Orange County
Orange, California 92868
United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California 94304
United States
Sharp Mary Birch Hospital for Woman and Newborns
San Diego, California 92123
United States
UF Health Shands Children's Hospital
Gainesville, Florida 32608
United States
Johns Hopkins Children's Center
Baltimore, Maryland 21287
United States
Children's of Mississippi
Jackson, Mississippi 39216
United States
The Children's Mercy Hospital
Kansas City, Missouri 64108
United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri 63104
United States
Duke Children's Hospital & Health Center
Durham, North Carolina 27705
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Medical University of South Carolina
Columbia, South Carolina 29209
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
United States
Texas Children's Hospital
Houston, Texas 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Primary Children's Hospital
Salt Lake City, Utah 84113
United States
Stollery Children's Hospital, University of Alberta
Edmonton, Alberta
Canada
IWK Health Centre
Halifax, Nova Scotia
Canada
The Hospital for Sick Children
Toronto, Ontario
Canada