Comparing cord clamping times for newborns with congenital heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare two different timepoints for clamping the umbilical cord in term-born infants diagnosed prenatally with congenital heart disease (CHD). Participants will be randomly assigned to either delayed cord clamping at 120 seconds or 30 seconds after birth. The study will assess health outcomes and neuromotor development at various postnatal ages using standardized assessments and questionnaires. The goal is to determine which clamping time leads to better overall health and developmental outcomes for these infants.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's of Alabama
  Birmingham, Alabama, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Sharp Mary Birch Hospital for Woman and Newborns
  San Diego, California, United States Recruiting
• UF Health Shands Children's Hospital
  Gainesville, Florida, United States Recruiting
• Johns Hopkins Children's Center
  Baltimore, Maryland, United States Recruiting
• Children's of Mississippi
  Jackson, Mississippi, United States Recruiting

Study contacts

• Principal investigator: Carl Backes, MD — Nationwide Children's Hospital
• Study coordinator: Carl Backes, MD
• Email: carl.backes@nationwidechildrens.org
• Phone: 614-355-6729

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving transition of congenital heart disease care from pediatric to adult services

  This program will try a multi-step transfer process to reduce health declines in people with congenital heart disease who are waiting to see an adult specialist.

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• HeartGPS: Prenatal mental health support for mothers of babies with CHD

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• Direct breastfeeding to support babies with congenital heart disease and their families

  This study tests a breastfeeding-focused program to help infants with CHD breastfeed directly and see how it affects infant health and parental well-being.

  Recruiting at 5 sites Carelon Research · Phoenix, Arizona and 16 other locations · NCT07582848

• Music and Multisensory Interventions for Pain During Chest Tube Removal in Infants with Congenital Heart Disease

  This trial tests whether music or a multisensory mobile intervention can reduce pain and stabilize physiology during chest tube removal in 2- to 12-month-old infants with congenital heart disease.

  Recruiting Baskent University · Ankara · NCT07564882

• MedlyPeds: a smartphone app to monitor kids with heart disease

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  Recruiting The Hospital for Sick Children · Toronto, Ontario · NCT07556185

• Fontan outcomes with low versus high lung blood flow in single‑ventricle hearts

  This project will test whether people with single‑ventricle congenital heart disease who have reduced versus increased pulmonary blood flow do better or worse after the Fontan operation.

  Recruiting National Cardiovascular Center Harapan Kita Hospital Indonesia · Jakarta, DKI Jakarta · NCT07535203

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.