CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 9 months
Healthy Volunteers: f
View:

• Fetal diagnosis of congenital heart disease (CHD) by prenatal ultrasound / echocardiography from local fetal ECHO, conducted on or after 18 weeks of gestation and prior to randomization. The study fetal diagnosis of CHD must be rated as 3 - 6 on the Fetal Cardiovascular Disease Severity Score (FCDSS), as determined by independent evaluators at the CORD-CHD trial ECHO Core at the Children's Hospital of Philadelphia (to determine final FCDSS eligibility for randomization).

• For each potential participant that has provided consent, the most relevant diagnostic prenatal ultrasound will be uploaded (shared) between 32 weeks of gestation and randomization for review by the ECHO Core. The ECHO Core will make the final FCDSS determination for eligibility status and stratification assignment.\]

• \[NOTE: A fetal diagnosis of CHD rated as 3 - 6 FCDSS per local review, including borderline cases, will be used to determine preliminary eligibility for consent. Among borderline cases, eligible patients will be included if there is a reasonable expectation of the need for surgery or cardiac catheterization during the birth hospitalization.\]

• Singleton gestation.

• Gestational age at randomization for impending deliveries between 37 0/7 - 41 6/7 weeks of gestation inclusive based on clinical information and evaluation of the earliest ultrasound determined using criteria proposed by the American Congress of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine and the Society for Maternal-Fetal Medicine.

• \[NOTE: Pregnant individuals who were admitted to the delivery hospital prior to 37 0/7 weeks of gestation remain eligible to randomize, provided they deliver within the 37 0/7 and 41 6/7 weeks eligibility window. Alternatively, if an eligible dyad is randomized at or just prior to 41 6/7 weeks, they remain in trial.\]

• Consent for the participant and their infant

Locations
United States
Alabama
Children's of Alabama
RECRUITING
Birmingham
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Children's Hospital of Orange County
NOT_YET_RECRUITING
Orange
Lucile Packard Children's Hospital Stanford
NOT_YET_RECRUITING
Palo Alto
Sharp Mary Birch Hospital for Woman and Newborns
RECRUITING
San Diego
Florida
UF Health Shands Children's Hospital
RECRUITING
Gainesville
Maryland
Johns Hopkins Children's Center
RECRUITING
Baltimore
Missouri
The Children's Mercy Hospital
RECRUITING
Kansas City
SSM Health Cardinal Glennon Children's Hospital
RECRUITING
St Louis
Mississippi
Children's of Mississippi
RECRUITING
Jackson
North Carolina
Duke Children's Hospital & Health Center
RECRUITING
Durham
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
RECRUITING
Columbia
Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
RECRUITING
Nashville
Texas
Texas Children's Hospital
RECRUITING
Houston
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Other Locations
Canada
Stollery Children's Hospital, University of Alberta
RECRUITING
Edmonton
IWK Health Centre
RECRUITING
Halifax
The Hospital for Sick Children
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Carl Backes, MD
carl.backes@nationwidechildrens.org
614-355-6729
Backup
Chelsea E Cobe, BA
chelsea.cobe@nationwidechildrens.org
614-355-6651
Time Frame
Start Date: 2023-12-19
Estimated Completion Date: 2030-12
Participants
Target number of participants: 500
Treatments
Active_comparator: Delayed Cord Clamping at 30 Seconds (DCC-30)
The umbilical cord will be clamped between 1 - \<60 seconds following delivery, with a goal of around 30 seconds.
Active_comparator: Delayed Cord Clamping at 120 Seconds (DCC-120)
The umbilical cord will be clamped at 60 - 180- seconds following delivery, with a goal of around 120 seconds.~In the DCC-120 group, if there is concern for pregnant individual or baby and their doctor is not able to wait until at least 60 seconds, the doctor may do cord milking, which is four gentle squeezes of the umbilical cord pushing blood from the placenta to baby.
Related Therapeutic Areas
Sponsors
Collaborators: Université de Montréal, Emory University, The George Washington University Biostatistics Center, Boston Children's Hospital, Children's Hospital of Philadelphia, University of Bristol, Geisinger Commonwealth School of Medicine, Duke University, National Heart, Lung, and Blood Institute (NHLBI), Sharp Mary Birch Hospital for Women & Newborns
Leads: Carl Backes, MD

This content was sourced from clinicaltrials.gov