Actively Recruiting
Cord Clamping Among Neonates With Congenital Heart Disease
Led by Carl Backes, MD · Updated on 2025-08-05
500
Participants Needed
21
Research Sites
362 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
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.
CONDITIONS
Official Title
Cord Clamping Among Neonates With Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fetal diagnosis of congenital heart disease rated 3 to 6 on the Fetal Cardiovascular Disease Severity Score by ultrasound after 18 weeks gestation
- Singleton pregnancy
- Gestational age between 37 0/7 and 41 6/7 weeks at randomization
- Consent obtained for participation of mother and infant
You will not qualify if you...
- Pregnant individual is a gestational carrier or surrogate
- Significant medical compromise of the pregnant individual (e.g., vasa previa, placental accreta with hypotension, placental abruption, amniotic fluid embolism, uterine rupture, uterine inversion, disseminated intravascular coagulation)
- Fetal demise or planned termination before randomization
- Fetal tachyarrhythmia requiring transplacental therapy
- Severe fetal hydrops
- Planned fetal surgery
- Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
- Major chromosomal defects such as Trisomy 13 or 18 (Trisomy 21 allowed)
- Disease or disorder affecting eligibility for neonatal cardiac interventions
- Parents choosing to limit treatment
- Delivery planned at a non-affiliated or non-referring institution
- Participation in another prenatal study affecting cord clamping or perinatal outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
C
Carl Backes, MD
CONTACT
C
Chelsea E Cobe, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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