← Back to Search

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

Must not have

Planned fetal surgery

Major chromosomal defects identified prenatally (e.g., Trisomy 13, 18)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-4 months after birth

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am scheduled for surgery on my unborn baby.

Select...

My unborn baby has been diagnosed with a major chromosomal defect.

Select...

I have a neuromuscular disorder like holoprosencephaly.

Select...

I need medication for my irregular heartbeat that can be given through the placenta.

Select...

I have a heart condition caused by my immune system.

Select...

I have a birth defect involving my diaphragm or abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-4 months after birth

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global Rank Score (Infant participant)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met