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Comparing cord clamping times for newborns with congenital heart disease

CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease

Not applicable Interventional Nationwide Children's Hospital · NCT06153459

This study is testing whether clamping the umbilical cord for 30 seconds or 120 seconds after birth helps newborns with congenital heart disease have better health and development.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment500 (estimated)
Ages37 Weeks to 42 Weeks
SexAll
SponsorNationwide Children's Hospital Academic / other
Locations21 sites (Birmingham, Alabama and 20 other locations)
Trial IDNCT06153459 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are term-born infants with a prenatal diagnosis of congenital heart disease rated 3-6 on the Fetal Cardiovascular Disease Severity Score.

Not a fit: Patients without a prenatal diagnosis of congenital heart disease or those rated below 3 on the FCDSS may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve health and developmental outcomes for newborns with congenital heart disease.

How similar studies have performed: Other studies have explored cord clamping practices, but this specific comparison of timing in the context of congenital heart disease is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Congenital Heart Diseasecord clampingechocardiographycongenital heart diseaseCORD-CHD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.