Timing of umbilical cord clamping among infants with congenital heart disease.
Laura Marzec, Eli Zettler, Clifford L Cua...
https://pubmed.ncbi.nlm.nih.gov/34113067Actively Recruiting
Phase Not Applicable
Age: 37Weeks - 42Weeks
All Genders
ID06153459
CORD-CHD: Comparing Delayed Umbilical Cord Clamping Times at 30 or 120 Seconds in Newborns with Congenital Heart Disease
Led by Carl Backes, MD · Updated on 2025-08-05
500
Participants Needed
21
Research Sites
113 weeks
Total Duration
On this page
Sponsors
C
Carl Backes, MD
Lead Sponsor
T
The George Washington University Biostatistics Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two different times to clamp the umbilical cord at birth for full-term babies diagnosed before birth with congenital heart disease (CHD). The study aims to find out whether clamping the cord at 120 seconds or at 30 seconds after birth leads to better overall health and neuromotor outcomes by 22 to 26 months of age. This trial focuses on infants with significant CHD and explores how timing affects their health and development. Participants will be randomly assigned to one of two groups: one where the umbilical cord is clamped around 30 seconds after birth, and another where the cord is clamped around 120 seconds after birth. In the longer delay group, if there are concerns about the baby or mother, doctors may perform umbilical cord milking before clamping. The study procedures include these interventions at birth and follow-up assessments over the first two years of life. During the study, infants will have developmental and neurological tests at 3-4 months, 9-12 months, and 22-26 months of age. Researchers will collect data from medical records for both mother and baby. Parents will also complete surveys about the impact of CHD on their child and family. The main outcomes include health status up to 30 days after heart interventions and neuromotor development up to two years old.
CONDITIONS
Brief Title
Cord Clamping Among Neonates With Congenital Heart Disease
Who Can Participate
Age: 37Weeks - 42Weeks
All Genders
Eligibility Criteria
You may qualify if you...
- Baby has a prenatal diagnosis of congenital heart disease rated 3 to 6 on the Fetal Cardiovascular Disease Severity Score
- Pregnancy with a single baby (singleton gestation)
- Gestational age between 37 0/7 and 41 6/7 weeks at randomization
- Consent provided for both the pregnant individual and infant
You will not qualify if you...
- Pregnant individual is a gestational carrier or surrogate
- Pregnant individual has severe complications such as vasa previa, placental accreta with low blood pressure, placental abruption, amniotic fluid embolism, uterine rupture or inversion, or blood clotting disorders
- Fetal demise or planned pregnancy termination before randomization
- Fetus has severe tachyarrhythmia needing treatment through the placenta
- Severe fetal hydrops
- Planned fetal surgery
- Fetus has diaphragmatic hernia, omphalocele, gastroschisis, or intestinal atresia
- Major chromosomal defects like Trisomy 13 or 18 (Trisomy 21 allowed)
- Disease preventing neonatal heart interventions
- Parents plan to limit treatment for the baby
- Delivery planned outside of a participating hospital
- Participation in another prenatal study affecting cord clamping or newborn health
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - At birth
Participants undergo umbilical cord clamping either at approximately 30 seconds or 120 seconds after birth as part of the study intervention. In some cases within the 120-second group, umbilical cord milking may be performed if clamping before 60 seconds is necessary.
1 visit (delivery)
Follow-up
Duration - Up to 26 months after birth
Participants and their caregivers are followed up to assess infant health outcomes, neuromotor and neurodevelopmental status, and parental perspectives over several months after birth.
Follow-up visits at 3-4 months, 9-12 months, and 22-26 months after birth
Trial Site Locations
Total: 21 locations
1
Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Children's Hospital of Orange County
Orange, California, United States, 92868
Not Yet Recruiting
4
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Not Yet Recruiting
5
Sharp Mary Birch Hospital for Woman and Newborns
San Diego, California, United States, 92123
Actively Recruiting
6
UF Health Shands Children's Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
7
Johns Hopkins Children's Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
8
Children's of Mississippi
Jackson, Mississippi, United States, 39216
Actively Recruiting
9
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
10
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, United States, 63104
Actively Recruiting
11
Duke Children's Hospital & Health Center
Durham, North Carolina, United States, 27705
Actively Recruiting
12
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
13
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
Medical University of South Carolina
Columbia, South Carolina, United States, 29209
Actively Recruiting
15
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
16
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
17
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
18
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
19
Stollery Children's Hospital, University of Alberta
Edmonton, Alberta, Canada
Actively Recruiting
20
IWK Health Centre
Halifax, Nova Scotia, Canada
Actively Recruiting
21
The Hospital for Sick Children
Toronto, Ontario, Canada
Not Yet Recruiting
Loading map...
Research Team
C
Carl Backes, MD
C
Chelsea E Cobe, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Early versus delayed umbilical cord clamping in infants with congenital heart disease: a pilot, randomized, controlled trial.
C H Backes, H Huang, C L Cua...
https://pubmed.ncbi.nlm.nih.gov/26226244Umbilical cord clamping among infants with a prenatal diagnosis of congenital heart disease.
Elliott L Fite, Brian K Rivera, Riley McNabb...
https://pubmed.ncbi.nlm.nih.gov/37002126