Cord Clamping Among Neonates With Congenital Heart Disease

NCT06153459 | Recruiting DMC

• 3 other identifiers: STUDY00003337UG3HL166794UG3HL166799
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 21

Brief 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.

Conditions

Congenital Heart Disease (CHD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Global Rank Score (Infant participant)

  Mortality=97;Heart transplant=96;Complication preventing cardiac intervention=95;Pre or Post-intervention neurologic complication=95;Pre or Post-intervention respiratory failure w/tracheostomy=95;Renal failure permanent dialysis=95;Unplanned cardiac surgery after initial cardiac intervention=94;Cardiac arrest=94;Pre or Post-intervention multisystem organ failure=94;Mechanical circulatory support=94;Pre-intervention polycythemia w/exchange transfusion/hemodilution=93;Unplanned cardiac catheterization after initial cardiac intervention=93;Pre-intervention mechanical ventilation=93;Pre-intervention necrotizing enterocolitis(Bell's II/III)=93;Pre-intervention shock=93;Pre-intervention unplanned hospitalization=93;Post-intervention bleeding reoperation=93;Delayed sternal closure=93;Pre-intervention renal failure temporary dialysis=93;Post-intervention renal failure, temporary dialysis=92;Post-intervention mechanical ventilation \>7 days=92;Hospital length of stay \>90 days=91,1-90 days=1-90

  Up to 30 days post-discharge following congenital heart disease intervention

Secondary Outcomes (20)

• Neuromotor Outcomes at 3-4 months of age (Infant participant)

  3-4 months after birth

• Impact of infant's congenital heart disease (Parents / Caregivers)

  3-4 months after birth

• Impact of infant's congenital heart disease (Parents / Caregivers)

  3-4 months after birth

• Impact of infant's congenital heart disease (Parents / Caregivers)

  9-12 months after birth

• Impact of infant's congenital heart disease (Parents / Caregivers)

  9-12 months after birth

Study Arms (2)

Delayed Cord Clamping at 30 Seconds (DCC-30)

ACTIVE COMPARATOR

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

Delayed Cord Clamping at 120 Seconds (DCC-120)

ACTIVE COMPARATOR

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; Procedure: Umbilical Cord Milking

Interventions

Umbilical Cord Clamping at ~30 seconds PROCEDURE

Care team will wait to clamp the umbilical between 1-\<60 seconds after birth. 30 seconds is the ideal time of clamping.

Also known as: Randomized to DCC-30 Group

Delayed Cord Clamping at 30 Seconds (DCC-30)

Umbilical Cord Clamping at ~120 seconds PROCEDURE

Care team will wait to clamp the umbilical cord between 60-180 seconds after birth.120 seconds is the ideal time of clamping

Also known as: Randomized to DCC-120 Group

Delayed Cord Clamping at 120 Seconds (DCC-120)

Umbilical Cord Milking PROCEDURE

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.

Delayed Cord Clamping at 120 Seconds (DCC-120)

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Pregnant individual is a gestational carrier or surrogate.
• 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 demise or planned termination of pregnancy prior to randomization
• Tachyarrhythmia requiring transplacental therapy
• Fetal hydrops, severe
• Planned fetal surgery
• Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
• Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed
• Disease or disorder impacting candidacy for neonatal cardiac interventions
• Parents choosing to limit treatment
• Delivery planned at an institution not affiliated with or does not refer to a CORD-CHD participating site
• Participation in another prenatal interventional study that influences cord clamping or perinatal morbidity or mortality

Sponsors & Collaborators

• Carl Backes, MD: lead
• The George Washington University Biostatistics Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Emory University: collaborator
• Boston Children's Hospital: collaborator
• University of Bristol: collaborator
• Geisinger Commonwealth School of Medicine: collaborator
• Duke University: collaborator
• Children's Hospital of Philadelphia: collaborator
• Sharp Mary Birch Hospital for Women & Newborns: collaborator
• Université de Montréal: collaborator

Study Sites (21)

Children's of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

NOT YET RECRUITING

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

NOT YET RECRUITING

Sharp Mary Birch Hospital for Woman and Newborns

San Diego, California, 92123, United States

RECRUITING

UF Health Shands Children's Hospital

Gainesville, Florida, 32608, United States

RECRUITING

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

RECRUITING

Children's of Mississippi

Jackson, Mississippi, 39216, United States

RECRUITING

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

SSM Health Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

RECRUITING

Duke Children's Hospital & Health Center

Durham, North Carolina, 27705, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Medical University of South Carolina

Columbia, South Carolina, 29209, United States

RECRUITING

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

RECRUITING

Stollery Children's Hospital, University of Alberta

Edmonton, Alberta, Canada

RECRUITING

IWK Health Centre

Halifax, Nova Scotia, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

NOT YET RECRUITING

Related Publications (3)

• Marzec L, Zettler E, Cua CL, Rivera BK, Pasquali S, Katheria A, Backes CH. Timing of umbilical cord clamping among infants with congenital heart disease. Prog Pediatr Cardiol. 2020 Dec;59:101318. doi: 10.1016/j.ppedcard.2020.101318. Epub 2020 Oct 28.

  PMID: 34113067 BACKGROUND

• Backes CH, Huang H, Cua CL, Garg V, Smith CV, Yin H, Galantowicz M, Bauer JA, Hoffman TM. Early versus delayed umbilical cord clamping in infants with congenital heart disease: a pilot, randomized, controlled trial. J Perinatol. 2015 Oct;35(10):826-31. doi: 10.1038/jp.2015.89. Epub 2015 Jul 30.

  PMID: 26226244 BACKGROUND

• Fite EL, Rivera BK, McNabb R, Smith CV, Hill KD, Katheria A, Maitre N, Backes CH. Umbilical cord clamping among infants with a prenatal diagnosis of congenital heart disease. Semin Perinatol. 2023 Jun;47(4):151747. doi: 10.1016/j.semperi.2023.151747. Epub 2023 Mar 18. No abstract available.

  PMID: 37002126 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Carl Backes, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• Anup Katheria, MD

  Sharp Mary Birch Hospital for Women & Newborns

  PRINCIPAL INVESTIGATOR

• Kevin Hill, MD

  Duke Children's Hospital

  PRINCIPAL INVESTIGATOR

• Madeline Rice, PhD

  George Washington University Biostatistics Center

  PRINCIPAL INVESTIGATOR

• Grecio (Greg) Sandoval, PhD

  George Washington University Biostatistics Center

  PRINCIPAL INVESTIGATOR

• Scott Evans, PhD

  George Washington University Biostatistics Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Backes, MD

CONTACT

614-355-6729; carl.backes@nationwidechildrens.org

Chelsea E Cobe, BA

CONTACT

614-355-6651; chelsea.cobe@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: December 1, 2023
• Study Start: December 19, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 2 years after primary publication
• Access Criteria: An archived dataset with documentation will be made available for additional uses by outside investigators, in collaboration with the study investigators. We will work with NIH/NHLBI program staff to develop a broad data sharing plan over time.

Locations

US (18); CA (3)