Condition: Congenital Heart Disease (CHD) · Sponsor: Carl Backes, MD
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.
This description comes directly from the study's public registry record.
Carl Backes, MD · 614-355-6729 · carl.backes@nationwidechildrens.org
Chelsea E Cobe, BA · 614-355-6651 · chelsea.cobe@nationwidechildrens.org
Always discuss trial participation with your own doctor first.
| Children's of Alabama | Birmingham, Alabama, United States | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | 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 | Recruiting |
| UF Health Shands Children's Hospital | Gainesville, Florida, United States | Recruiting |
| Johns Hopkins Children's Center | Baltimore, Maryland, United States | Recruiting |
| Children's of Mississippi | Jackson, Mississippi, United States | Recruiting |
| The Children's Mercy Hospital | Kansas City, Missouri, United States | Recruiting |
| SSM Health Cardinal Glennon Children's Hospital | St Louis, Missouri, United States | Recruiting |
| Duke Children's Hospital & Health Center | Durham, North Carolina, United States | Recruiting |
| Nationwide Children's Hospital | Columbus, Ohio, United States | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06153459