Timing of umbilical cord clamping among infants with congenital heart disease.
Laura Marzec, Eli Zettler, Clifford L Cua...
https://pubmed.ncbi.nlm.nih.gov/34113067/Actively Recruiting
Led by Carl Backes, MD · Updated on 2026-08-12
500
Participants Needed
21
Research Sites
113 weeks
Total Duration
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
Cord Clamping Among Neonates With Congenital Heart Disease
C
Carl Backes, MD
C
Chelsea E Cobe, BA
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Carl Backes, MD
Lead Sponsor
The George Washington University Biostatistics Center
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | DCC‑30 | DCC‑120 |
|---|---|---|
| What it is | Clamping the umbilical cord approximately 30 seconds after birth | Clamping the umbilical cord approximately 120 seconds after birth |
| Role in trial | One of two randomized timing groups | One of two randomized timing groups |
| Primary use | Assess whether near‑immediate delayed clamping affects outcomes in infants with congenital heart disease | Assess whether extended delayed clamping affects outcomes in infants with congenital heart disease |
| How it is performed | Umbilical cord is clamped roughly 30 seconds after birth | Umbilical cord is clamped roughly 120 seconds after birth |
| Evidence status | Safety and feasibility have been explored in a prior pilot randomized trial showing similar safety to early clamping and fewer transfusions in delayed groups | Previous pilot trial suggests feasibility and possible benefit such as lower transfusion need; comprehensive evidence still limited |
| Important risks | Not yet fully known; potential for higher bilirubin levels or polycythemia suggested by small trials | Not yet fully known; small studies noted trends toward elevated bilirubin and hematocrit changes |
| Important limitations | Evidence is limited to small pilot trials; current study will provide larger sample data | Evidence is limited to small pilot trials; comprehensive outcomes in CHD population remain unestablished |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At birth
Participants will have their umbilical cord clamped at either about 30 seconds or about 120 seconds after birth, based on random assignment. In some cases, cord milking may be performed if needed in the delayed group.
Duration - Up to 26 months after birth
Participants complete neuromotor assessments and questionnaires at 3-4 months, 9-12 months, and 22-26 months after birth to evaluate development and health.
Multiple follow-up visits
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Laura Marzec, Eli Zettler, Clifford L Cua...
https://pubmed.ncbi.nlm.nih.gov/34113067/Elliott L Fite, Brian K Rivera, Riley McNabb...
https://pubmed.ncbi.nlm.nih.gov/37002126/C H Backes, H Huang, C L Cua...
https://pubmed.ncbi.nlm.nih.gov/26226244/Carl Backes, MD
Lead Sponsor
The George Washington University Biostatistics Center
Collaborating Sponsor