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Phase Not Applicable
Age: 37Weeks - 42Weeks
All Genders
ID06153459

Comparing Early vs. Delayed Umbilical Cord Clamping in Newborns With Congenital Heart Disease Assessing Health and Neuromotor Outcomes up to 26 Months

Led by Carl Backes, MD · Updated on 2026-08-12

500

Participants Needed

21

Research Sites

113 weeks

Total Duration

AI-Summary

What this Trial Is About

This clinical trial evaluates two different times for clamping the umbilical cord at birth in babies with a prenatal diagnosis of congenital heart disease CHD. It aims to determine whether delaying cord clamping to around 120 seconds or 30 seconds after birth leads to better health and neuromotor outcomes in these infants. The study focuses on term-born babies with significant CHD and seeks to understand which timing may improve overall infant health and development. Participants are randomly assigned to either have their umbilical cord clamped around 30 seconds or delayed to about 120 seconds after birth. In the 120-second group, if there are concerns about the baby or mother, the doctor may perform umbilical cord milking, which involves gently pushing blood from the placenta to the baby. The study includes follow-up assessments at 3-4 months, 9-12 months, and 22-26 months after birth to evaluate neuromotor development and caregiver perspectives. During the study, participants will undergo general movements assessments, neurological exams, developmental testing, and complete questionnaires about the infants condition. Medical records from both mother and infant will be reviewed. The main outcome measured is the global rank score of the infants health up to 30 days after discharge from the hospital following heart disease intervention. The study will continue until 2030, with detailed follow-up measures through the first two years of life.

CONDITIONS

Brief Title

Cord Clamping Among Neonates With Congenital Heart Disease

Research Team

C

Carl Backes, MD

C

Chelsea E Cobe, BA

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