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.
Congenital Heart Disease (CHD)
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.
Cord Clamping Among Neonates with Congenital Heart Disease
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Children's of Alabama, Birmingham, Alabama, United States, 35233
Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048
Children's Hospital of Orange County, Orange, California, United States, 92868
Lucile Packard Children's Hospital Stanford, Palo Alto, California, United States, 94304
Sharp Mary Birch Hospital for Woman and Newborns, San Diego, California, United States, 92123
UF Health Shands Children's Hospital, Gainesville, Florida, United States, 32608
Johns Hopkins Children's Center, Baltimore, Maryland, United States, 21287
Children's of Mississippi, Jackson, Mississippi, United States, 39216
The Children's Mercy Hospital, Kansas City, Missouri, United States, 64108
SSM Health Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States, 63104
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.
37 Weeks to 42 Weeks
ALL
No
Carl Backes, MD,
Carl Backes, MD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital
Anup Katheria, MD, PRINCIPAL_INVESTIGATOR, Sharp Mary Birch Hospital for Women & Newborns
Kevin Hill, MD, PRINCIPAL_INVESTIGATOR, Duke Children's Hospital
Madeline Rice, PhD, PRINCIPAL_INVESTIGATOR, George Washington University Biostatistics Center
Grecio (Greg) Sandoval, PhD, PRINCIPAL_INVESTIGATOR, George Washington University Biostatistics Center
Scott Evans, PhD, PRINCIPAL_INVESTIGATOR, George Washington University Biostatistics Center
2030-12