Cord Clamping Among Neonates With Congenital Heart Disease
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:
🦠 Congenital Heart Disease (CHD)
🗓️ Study Start (Actual) 19 December 2023
🗓️ Primary Completion (Estimated) October 2028
✅ Study Completion (Estimated) December 2030
👥 Enrollment (Estimated) 500
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States
📍 Los Angeles, California, United States
📍 Orange, California, United States
📍 Palo Alto, California, United States
📍 San Diego, California, United States
📍 Gainesville, Florida, United States
📍 Baltimore, Maryland, United States
📍 Jackson, Mississippi, United States
📍 Kansas City, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Durham, North Carolina, United States
📍 Columbus, Ohio, United States
📍 Philadelphia, Pennsylvania, United States
📍 Columbia, South Carolina, United States
📍 Nashville, Tennessee, United States
📍 Houston, Texas, United States
📍 San Antonio, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Edmonton, Alberta, Canada
📍 Halifax, Nova Scotia, Canada
📍 Toronto, Ontario, Canada

📋 Eligibility Criteria

Description

  • 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 between 18 - 36 weeks of gestation. 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 and 36 weeks of gestation 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 labor and delivery admission (randomization) 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.
  • \[NOTE: Pregnant individuals who were admitted to the delivery hospital prior to 37 0/7 weeks of gestation remain eligible, provided they deliver within the 37 0/7 and 41 6/7 weeks "eligibility window".\]
  • 4. Informed consent to participate for both the pregnant individual 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
  • \[NOTE: There is no limitation on pregnant individual's age\]

Exclusion Criteria:

  • 1. Fetal demise or planned termination of pregnancy prior to randomization
  • 2. Tachyarrhythmia requiring transplacental therapy
  • 3. Fetal hydrops, severe
  • 4. Autoimmune myocardial disease
  • 5. Planned fetal surgery
  • 6. Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
  • 7. Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed
  • 8. Neuromuscular disorders (e.g., holoprosencephaly)
  • 9. Parents choosing to limit treatment
  • 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
Ages Eligible for Study: 37 Weeks to 42 Weeks (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 12 November 2023
  • First Submitted that Met QC Criteria 22 November 2023
  • First Posted 1 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024