Purpose

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.

Condition

Eligibility

Eligible Ages
Between 37 Weeks and 42 Weeks
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Procedure: Umbilical Cord Clamping at ~30 seconds
    Care team will wait to clamp the umbilical between 1-<60 seconds after birth. 30 seconds is the ideal time of clamping.
    Other names:
    • Randomized to DCC-30 Group
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.
  • Procedure: Umbilical Cord Clamping at ~120 seconds
    Care team will wait to clamp the umbilical cord between 60-180 seconds after birth.120 seconds is the ideal time of clamping
    Other names:
    • Randomized to DCC-120 Group
  • Procedure: Umbilical Cord Milking
    For infants who need their cord clamped before the target in the DCC-120 group. Care team may milk the umbilical cord towards the infant four times. Cord milking should NOT be performed if the delay meets or exceeds 60 seconds. Umbilical cord milking will not be provided among participant-infant dyads in the DCC-30 group.

Recruiting Locations

Children's of Alabama
Birmingham, Alabama 35233
Contact:
Andrea Kane, MD
akane@uabmc.edu

Cedars-Sinai Medical Center
Los Angeles, California 90048
Contact:
Ruchira Garg, MD
ruchira.garg@cshs.org

Sharp Mary Birch Hospital for Woman and Newborns
San Diego, California 92123
Contact:
Anup Katheria, MD
anup.katheria@sharp.com

UF Health Shands Children's Hospital
Gainesville, Florida 32608
Contact:
Jennifer Co-Vu, MD
jcovu@mail.ufl.edu

Johns Hopkins Children's Center
Baltimore, Maryland 21287
Contact:
Victoria Surma, MD
vsurma1@jhmi.edu

Children's of Mississippi
Jackson, Mississippi 39216
Contact:
Simon Karam, MD
skaram@umc.edu

The Children's Mercy Hospital
Kansas City, Missouri 64108
Contact:
John Daniel, MD
jmdaniel@cmh.edu

SSM Health Cardinal Glennon Children's Hospital
Saint Louis, Missouri 63104
Contact:
Justin Josephsen, MD
justin.josephsen@health.slu.edu

Duke Children's Hospital & Health Center
Durham, North Carolina 27705
Contact:
Kevin Hill
kevin.hill@duke.edu

Nationwide Children's Hospital
Columbus, Ohio 43205
Contact:
Carl H. Backes, MD
6142646374
Carl.Backes@nationwidechildrens.org

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
Contact:
Elizabeth Foglia, MD
foglia@chop.edu

Medical University of South Carolina
Columbia, South Carolina 29209
Contact:
Sinai Zyblewski, MD
chois@musc.edu

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
Contact:
Prince Kannankeril, MD
prince.kannankeril@vumc.org

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
J.B. Cantey, MD
cantey@uthsca.edu

Primary Children's Hospital
Salt Lake City, Utah 84113
Contact:
Ryan Carpenter, MD
ryan.carpenter@hsc.utah.edu

More Details

NCT ID
NCT06153459
Status
Recruiting
Sponsor
Carl Backes, MD

Study Contact

Carl Backes, MD
614-355-6729
carl.backes@nationwidechildrens.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.