Umbilical Cord Clamping for Neonates with Congenital Heart Disease
This study is looking at the best time to clamp the umbilical cord for full-term babies born with congenital heart disease (CHD), a heart problem present at birth. Researchers want to see if clamping the cord at about 30 seconds (DCC-30) or about 120 seconds (DCC-120) after birth leads to better health and movement skills for these babies. They will compare these two timing options. To join, your baby must be between 37 and 42 weeks old and have a prenatal diagnosis of CHD with a specific severity score (3-6 on the Fetal Cardiovascular Disease Severity Score). The study aims to find out which clamping time results in better overall health outcomes and better neuromotor (brain and movement) development for the infant.
- Study design
- This is an interventional study planning to enroll 500 participants. Participants will be randomly assigned to either the DCC-120 or DCC-30 group.
- What's involved
- Participants will have their umbilical cord clamped at either 30 or 120 seconds after birth. They will also complete a General Movements Assessment (GMA) and questionnaires at 3-4 months of age.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed up to 30 days after discharge from congenital heart disease intervention, and neuromotor outcomes will be assessed at 22-26 months of infant age.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cord Clamping Among Neonates With Congenital Heart Disease
At a glance
Conditions
NCT06153459
Where you'd take part
This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cedars-Sinai Medical Center
Los Angeles, Californiastudy coordinator listed
Recruiting
Children's Hospital of Orange County
Orange, Californiastudy coordinator listed
Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Children's of Alabama
Birmingham, Alabamastudy coordinator listed
Recruiting
Children's of Mississippi
Jackson, Mississippistudy coordinator listed
Recruiting
Duke Children's Hospital & Health Center
Durham, North Carolinastudy coordinator listed
Recruiting
IWK Health Centre
Halifax, Nova Scotia, Canadastudy coordinator listed
Recruiting
Johns Hopkins Children's Center
Baltimore, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- 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
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Global Rank Score (Infant participant)Up to 30 days post-discharge following congenital heart disease intervention
Mortality=97;Heart transplant=96;Complication preventing cardiac intervention=95;Pre or Post-intervention neurologic complication=95;Pre or Post-intervention respiratory failure w/tracheostomy=95;Renal failure permanent dialysis=95;Unplanned cardiac surgery after initial cardiac intervention=94;Cardiac arrest=94;Pre or Post-intervention multisystem organ failure=94;Mechanical circulatory support=94;Pre-intervention polycythemia w/exchange transfusion/hemodilution=93;Unplanned cardiac catheterization after initial cardiac intervention=93;Pre-intervention mechanical ventilation=93;Pre-intervention necrotizing enterocolitis(Bell's II/III)=93;Pre-intervention shock=93;Pre-intervention unplanned hospitalization=93;Post-intervention bleeding reoperation=93;Delayed sternal closure=93;Pre-intervention renal failure temporary dialysis=93;Post-intervention renal failure, temporary dialysis=92;Post-intervention mechanical ventilation \>7 days=92;Hospital length of stay \>90 days=91,1-90 days=1-90