RECRUITING

Cord Clamping Among Neonates with Congenital Heart Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CORD-CHD: Clamp or Delay Among Neonates with Congenital Heart Disease

Quick Facts

Study Start:2023-12-19
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06153459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:37 Weeks to 42 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Fetal demise or planned termination of pregnancy prior to randomization
  2. 2. Tachyarrhythmia requiring transplacental therapy
  3. 3. Fetal hydrops, severe
  4. 4. Autoimmune myocardial disease
  5. 5. Planned fetal surgery
  6. 6. Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
  7. 7. Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed
  8. 8. Neuromuscular disorders (e.g., holoprosencephaly)
  9. 9. Parents choosing to limit treatment

Contacts and Locations

Study Contact

Carl Backes, MD
CONTACT
614-355-6729
carl.backes@nationwidechildrens.org
Chelsea E Cobe, BA
CONTACT
614-355-6651
chelsea.cobe@nationwidechildrens.org

Principal Investigator

Carl Backes, MD
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Anup Katheria, MD
PRINCIPAL_INVESTIGATOR
Sharp Mary Birch Hospital for Women & Newborns
Kevin Hill, MD
PRINCIPAL_INVESTIGATOR
Duke Children's Hospital
Madeline Rice, PhD
PRINCIPAL_INVESTIGATOR
George Washington University Biostatistics Center
Grecio (Greg) Sandoval, PhD
PRINCIPAL_INVESTIGATOR
George Washington University Biostatistics Center
Scott Evans, PhD
PRINCIPAL_INVESTIGATOR
George Washington University Biostatistics Center

Study Locations (Sites)

Children's of Alabama
Birmingham, Alabama, 35233
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
United States
Sharp Mary Birch Hospital for Woman and Newborns
San Diego, California, 92123
United States
UF Health Shands Children's Hospital
Gainesville, Florida, 32608
United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
United States
Children's of Mississippi
Jackson, Mississippi, 39216
United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
SSM Health Cardinal Glennon Children's Hospital
Saint Louis, Missouri, 63104
United States
Duke Children's Hospital & Health Center
Durham, North Carolina, 27705
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Medical University of South Carolina
Columbia, South Carolina, 29209
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States

Collaborators and Investigators

Sponsor: Carl Backes, MD

  • Carl Backes, MD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital
  • Anup Katheria, MD, PRINCIPAL_INVESTIGATOR, Sharp Mary Birch Hospital for Women & Newborns
  • Kevin Hill, MD, PRINCIPAL_INVESTIGATOR, Duke Children's Hospital
  • Madeline Rice, PhD, PRINCIPAL_INVESTIGATOR, George Washington University Biostatistics Center
  • Grecio (Greg) Sandoval, PhD, PRINCIPAL_INVESTIGATOR, George Washington University Biostatistics Center
  • Scott Evans, PhD, PRINCIPAL_INVESTIGATOR, George Washington University Biostatistics Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-19
Study Completion Date2030-12

Study Record Updates

Study Start Date2023-12-19
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • cord clamping
  • echocardiography (ECHO)
  • congenital heart disease (CHD)
  • CORD-CHD

Additional Relevant MeSH Terms

  • Congenital Heart Disease (CHD)