Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could waiting longer to clamp the cord boost outcomes for babies with heart defects?

NCT ID NCT06153459

Disease control Sponsor: Carl Backes, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial asks whether clamping the umbilical cord at 120 seconds after birth is better than clamping at 30 seconds for babies born with congenital heart disease. About 500 infants with a prenatal heart defect diagnosis will be randomly assigned to one of the two timings. Researchers will track health outcomes shortly after birth and check motor and brain development at 3-4 months, 9-12 months, and 22-26 months of age. The goal is to find out which approach gives these babies the best start.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Umbilical cord clamping at 30 seconds vs 120 seconds, or cord milking if early clamping is needed
What this could lead to
If one timing is better, it could become the standard way to manage cord clamping for babies with heart defects, potentially improving survival and brain development.
What could go wrong
This is an early-stage trial, and the best timing may not clearly outperform the other. There are also risks like breathing problems or blood issues that the trial will monitor.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

37 to 42 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Congenital heart disease (CHD) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital heart disease (CHD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Children's Hospital of Orange County

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Children's of Mississippi

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • Duke Children's Hospital & Health Center

    RECRUITING

    Durham, North Carolina, 27705, United States

  • IWK Health Centre

    RECRUITING

    Halifax, Nova Scotia, Canada

  • Johns Hopkins Children's Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lucile Packard Children's Hospital Stanford

    NOT_YET_RECRUITING

    Palo Alto, California, 94304, United States

  • Medical University of South Carolina

    RECRUITING

    Columbia, South Carolina, 29209, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • SSM Health Cardinal Glennon Children's Hospital

    RECRUITING

    St Louis, Missouri, 63104, United States

  • Sharp Mary Birch Hospital for Woman and Newborns

    RECRUITING

    San Diego, California, 92123, United States

  • Stollery Children's Hospital, University of Alberta

    RECRUITING

    Edmonton, Alberta, Canada

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • The Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • The Hospital for Sick Children

    NOT_YET_RECRUITING

    Toronto, Ontario, Canada

  • UF Health Shands Children's Hospital

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.