Back to Trials
NCT06153459NARecruiting

Cord Clamping Among Neonates With Congenital Heart Disease

Carl Backes, MD

Start Date

12/19/2023

Completion Date

12/1/2030

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.

Detailed Description

* AIM 1: Test the hypothesis that, among neonates with prenatally diagnosed significant CHD (ranking of 3 - 6 on the Fetal Cardiovascular Disease Severity Score \[FCDSS\]), DCC-120 results in lower global rank score (GRS), indicative of better health outcomes, compared with DCC-30. * AIM 2: Test the hypothesis that, among neonates with prenatally diagnosed significant CHD (ranking from 3 - 6 on the Fetal Cardiovascular Disease Severity Score \[FCDSS\]), DCC-120 will result in better neuromotor outcomes at 22-26 months postnatal than DCC-30.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion criteria are listed below and will be confirmed prior to randomization: 1. 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.\] \[NOTE: A fetal diagnosis of CHD rated as 3 - 6 FCDSS per local review, including borderline cases, will be used to determine preliminary eligibility for consent. Among borderline cases, eligible patients will be included if there is a reasonable expectation of the need for surgery or cardiac catheterization during the birth hospitalization.\] 2. Singleton gestation. 3. 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. \[NOTE: Pregnant individuals who were admitted to the delivery hospital prior to 37 0/7 weeks of gestation remain eligible to randomize, provided they deliver within the 37 0/7 and 41 6/7 weeks "eligibility window". Alternatively, if an eligible dyad is randomized at or just prior to 41 6/7 weeks, they remain in trial.\] 4. Consent for the participant and their infant Exclusion criteria are listed below and will be confirmed prior to randomization: Exclusion Criteria for Pregnant Individuals: 1. Pregnant individual is a gestational carrier or surrogate. 2. 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), as determined by local care team \[NOTE: There is no limitation on pregnant individual's age\] Fetal Exclusion Criteria: 1. Fetal demise or planned termination of pregnancy prior to randomization 2. Tachyarrhythmia requiring transplacental therapy 3. Fetal hydrops, severe 4. Planned fetal surgery 5. Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia 6. Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed 7. Disease or disorder impacting candidacy for neonatal cardiac interventions 8. Parents choosing to limit treatment Pregnancy Exclusion Criteria: 1. Delivery planned at an institution not affiliated with or does not refer to a CORD-CHD participating site 2. Participation in another prenatal interventional study that influences cord clamping or perinatal morbidity or mortality

Interventions

PROCEDURE

Umbilical Cord Clamping at ~30 seconds

PROCEDURE

Umbilical Cord Clamping at ~120 seconds

PROCEDURE

Umbilical Cord Milking

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Congenital Heart Disease (CHD)

Locations

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

St 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

Stollery Children's Hospital, University of Alberta

Edmonton, Alberta

Canada

IWK Health Centre

Halifax, Nova Scotia

Canada

The Hospital for Sick Children

Toronto, Ontario

Canada