Comparing two umbilical cord clamping times for babies born with congenital heart disease
Compares cord clamping at 30 seconds versus 120 seconds in babies with congenital heart disease.
Key facts
- Who runs it
- Carl Backes, MD
- Where
- Baltimore, Birmingham, Columbia, Columbus, Durham, Gainesville, Houston, Jackson, Kansas City, Los Angeles, Nashville, Orange, Palo Alto, Philadelphia, Salt Lake City, San Antonio, San Diego, and St Louis, United StatesSee the 18 sitesAlso in 1 other country, 3 sites
- Trial code
- Registry title
- Cord Clamping Among Neonates With Congenital Heart Disease
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 19 Dec 2023
- Expected to end
- Dec 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Umbilical Cord Clamping at ~30 seconds
- Umbilical Cord Clamping at ~120 seconds
- Umbilical Cord Milking
- Record updated
- 12 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant people carrying one baby who has been found to have a heart defect before birth. It compares clamping the umbilical cord at about 30 seconds or about 120 seconds after birth.
- Age
- Babies born between 37 and 42 weeks of pregnancy. There is no age limit for the pregnant person.
- Sex
- All
- Disease stage
- Heart defect in the baby found by ultrasound or heart scan at or after 18 weeks of pregnancy. It must score 3 - 6 on the Fetal Cardiovascular Disease Severity Score (FCDSS), confirmed by a central review team. Birth must be planned between 37 0/7 and 41 6/7 weeks.
- Earlier treatment
- Cannot join if fetal surgery is planned, or if the baby has a fast heart rhythm that needs treatment given through the mother.
Main reasons for not taking part
- The pregnant person is a gestational carrier or surrogate.
- Serious pregnancy problems such as vasa previa, placental abruption or uterine rupture.
- Severe fluid build-up in the baby (hydrops), or defects such as diaphragmatic hernia, omphalocele, gastroschisis or intestinal atresia.
- Major chromosome changes such as Trisomy 13 or 18. Trisomy 21 is allowed.
- Parents choosing to limit treatment, or birth planned at a hospital not linked to a study site.
This trial only enrols pregnant participants. The registry sentence this rests on: Singleton gestation.
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Fetal demise or planned termination of pregnancy prior to randomization
- Tachyarrhythmia requiring transplacental therapy
- Planned fetal surgery
- Disease or disorder impacting candidacy for neonatal cardiac interventions
- 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:
- Pregnant individual is a gestational carrier or surrogate
- Fetal hydrops, severe
- Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
- Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed
- Parents choosing to limit treatment; Pregnancy Exclusion Criteria:
- 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
Where in United States
Also in 1 other country, 3 sites
- Johns Hopkins Children's CenterBaltimore, United StatesContact: Victoria Surma, MDTaking people
- Children's of AlabamaBirmingham, United StatesContact: Andrea Kane, MDTaking people
- Medical University of South CarolinaColumbia, United StatesContact: Sinai Zyblewski, MDTaking people
- Nationwide Children's HospitalColumbus, United StatesContact: Carl H. Backes, MDTaking people
- Duke Children's Hospital & Health CenterDurham, United StatesContact: Kevin HillTaking people
- UF Health Shands Children's HospitalGainesville, United StatesContact: Jennifer Co-Vu, MDTaking people
- Texas Children's HospitalHouston, United StatesContact: Nathan Sundgren, MD, PhDTaking people
- Children's of MississippiJackson, United StatesContact: Simon Karam, MDTaking people
- The Children's Mercy HospitalKansas City, United StatesContact: John Daniel, MDTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Ruchira Garg, MDTaking people
- Monroe Carell Jr. Children's Hospital at VanderbiltNashville, United StatesContact: Prince Kannankeril, MDTaking people
- Children's Hospital of Orange CountyOrange, United StatesContact: Shawn Sen, MDNot yet recruiting
- Lucile Packard Children's Hospital - StanfordPalo Alto, United StatesContact: Alexis Davis, MDNot yet recruiting
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Elizabeth Foglia, MDTaking people
- Primary Children's HospitalSalt Lake City, United StatesContact: Ryan Carpenter, MDTaking people
- University of Texas Health Science Center at San AntonioSan Antonio, United StatesContact: J.B. Cantey, MDTaking people
- Sharp Mary Birch Hospital for Woman and NewbornsSan Diego, United StatesContact: Anup Katheria, MDTaking people
- SSM Health Cardinal Glennon Children's HospitalSt Louis, United StatesContact: Justin Josephsen, MDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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.
The 2 groups in the trial
- Delayed Cord Clamping at 30 Seconds (DCC-30)Existing treatment, for comparison
The umbilical cord will be clamped between 1 - \<60 seconds following delivery, with a goal of around 30 seconds.
Treatment: Umbilical Cord Clamping at ~30 seconds
- Delayed Cord Clamping at 120 Seconds (DCC-120)Existing treatment, for comparison
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.
Treatment: Umbilical Cord Clamping at ~120 seconds and Umbilical Cord Milking
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease
- Plain-language title
- Comparing two umbilical cord clamping times for babies born with congenital heart diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 12 August 2026