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Procedure

Delayed Cord Clamping Techniques for Newborns with Congenital Heart Disease (CORD-CHD Trial)

N/A
Recruiting
Led By Madeline Rice, PhD
Research Sponsored by Carl Backes, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fetal diagnosis of congenital heart disease (CHD) by prenatal ultrasound / echocardiography from local fetal ECHO, conducted between 18 - 36 weeks of gestation, rated as 3 - 6 on the Fetal Cardiovascular Disease Severity Score (FCDSS)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-4 months after birth
Awards & highlights

CORD-CHD Trial Summary

This trial will compare 2 delayed cord clamping techniques after birth for infants with CHD, to see which is more beneficial for both mother & baby.

Who is the study for?
This trial is for term-born infants with a prenatal diagnosis of congenital heart disease, rated moderate to severe. The mother must be at 37-41 weeks of gestation and give informed consent. Exclusions include surrogacy, certain maternal or fetal health conditions, major chromosomal defects, neuromuscular disorders, and participation in another study affecting cord clamping.Check my eligibility
What is being tested?
The trial compares the effects of delaying umbilical cord clamping for ~120 seconds (DCC-120) versus ~30 seconds (DCC-30) on health and neuromotor outcomes in infants with CHD up to about two years old. It involves assessments at multiple stages postnatal and data collection from medical records.See study design
What are the potential side effects?
While specific side effects are not detailed for this procedure-focused trial, potential risks may relate to the timing of cord clamping impacting infant blood volume and circulation immediately after birth.

CORD-CHD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My unborn baby has been diagnosed with a heart condition rated 3-6 on the FCDSS.

CORD-CHD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-4 months after birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-4 months after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Global Rank Score (Infant participant)
Secondary outcome measures
Delivery Complications and Outcomes (Pregnant individual participant)
Impact of infant's congenital heart disease (Parents / Caregivers)
Neurodevelopmental Outcomes at 22-26 months (Infant participant)
+2 more

CORD-CHD Trial Design

2Treatment groups
Active Control
Group I: Delayed Cord Clamping at 30 Seconds (DCC-30)Active Control1 Intervention
The umbilical cord will be clamped between 1 - <60 seconds following delivery, with a goal of around 30 seconds.
Group II: Delayed Cord Clamping at 120 Seconds (DCC-120)Active Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

Duke Children's Hospital & Health CenterUNKNOWN
Carl Backes, MDLead Sponsor
Duke UniversityOTHER
2,363 Previous Clinical Trials
3,420,016 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of the hospitals utilizing this research program?

"This medical research project is conducting patient recruitment at Lucile Packard Children's Hospital Stanford in Palo Alto, Alabama, Children's of Alabama in Birmingham, Ohio and Nationwide Children's Hospital in Columbus. Additionally, there are 21 other sites where people can take part."

Answered by AI

Is the age cap for this trial restricted to those under 45?

"This trial requires participants who are between 37 and 42 weeks in age. There are 107 trials for those younger than 18, while 249 exist for individuals aged over 65."

Answered by AI

Are additional participants currently being sought for this investigation?

"According to clinicaltrials.gov, this trial is not currently seeking participants, as the last update was made on November 22nd 2023. Despite that fact, there are still 337 other medical studies actively recruiting patients at present."

Answered by AI

Are there any eligibility requirements to enroll in this research trial?

"This clinical study is recruiting up to 500 people with congenital heart disease between the ages of 37 and 42 weeks."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cord Clamping Among Neonates With Congenital Heart Disease
Carl Backes, MD 2023. "Cord Clamping Among Neonates With Congenital Heart Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153459.
All > High Point > Greensboro
~333 spots leftby Oct 2028
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