Delayed Cord Clamping Techniques for Newborns with Congenital Heart Disease
(CORD-CHD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the optimal timing for clamping the umbilical cord in newborns with congenital heart disease, a condition affecting the heart's structure from birth. It compares clamping at 30 seconds versus 120 seconds after birth to determine which timing leads to better health and movement outcomes for babies. Parents expecting to deliver a single baby between 37 and 42 weeks, who have been informed of their unborn child's congenital heart disease, might be suitable candidates. Participants will be randomly assigned to one of the two timing groups and will undergo follow-up assessments to track development. As an unphased trial, this study provides a unique opportunity to contribute to important research that could improve outcomes for future newborns with congenital heart disease.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that these delayed cord clamping techniques are safe for newborns with congenital heart disease?
Research has shown that waiting before cutting the umbilical cord, known as delayed cord clamping, is generally safe for newborns, even those with congenital heart conditions. Studies have found that babies whose cords are clamped about two minutes after birth often require fewer blood transfusions, indicating safety.
For clamping at 30 seconds, evidence suggests this timing is well-tolerated, and any side effects are manageable. Both the 30-second and 120-second methods are considered safe. While experts continue to discuss the optimal timing for clamping, the methods used in these studies have demonstrated safety for both the baby and the mother.12345Why are researchers excited about this trial?
Researchers are excited about investigating delayed cord clamping techniques for newborns with congenital heart disease because these methods might improve early health outcomes. Unlike immediate cord clamping, which is typically done within seconds after birth, delayed clamping allows more time for blood from the placenta to transfer to the newborn, potentially increasing blood volume and improving oxygen levels. The trial explores two different timings: clamping at around 30 seconds and at around 120 seconds, as well as a technique called umbilical cord milking, which involves gently pushing blood toward the baby. These approaches could offer a simple, low-cost way to enhance early heart function and overall stability in these vulnerable newborns.
What evidence suggests that these delayed cord clamping techniques are effective for newborns with congenital heart disease?
Research has shown that waiting before clamping the umbilical cord can benefit newborns, especially those with congenital heart disease (CHD). This trial will assign participants to different arms to test the effects of delayed cord clamping. One arm will delay clamping for about 30 seconds, while another will delay for about 120 seconds. Studies have found that delaying cord clamping for 30 to 120 seconds can improve hemoglobin levels, aiding oxygen delivery throughout the body, and reduce the need for blood transfusions. Although there is some discussion about the optimal timing, both methods have been linked to positive outcomes for babies. Even a short delay in clamping the cord can provide these health benefits.13467
Who Is on the Research Team?
Anup Katheria, MD
Principal Investigator
Sharp Mary Birch Hospital for Women & Newborns
Carl H. Backes, MD
Principal Investigator
Nationwide Children's Hospital
Kevin Hill, MD
Principal Investigator
Duke Children's Hospital
Madeline Rice, PhD
Principal Investigator
George Washington University Biostatistics Center
Grecio (Greg) Sandoval, PhD
Principal Investigator
George Washington University Biostatistics Center
Scott Evans, PhD
Principal Investigator
George Washington University Biostatistics Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) at birth
Follow-up
Participants complete General Movements Assessment (GMA) at 3-4 months, questionnaires at 9-12 months, and HINE, DAYC-2, and questionnaires at 22-26 months postnatal
Data Collection
Data collection from electronic medical records for both the mother and infant study participants
What Are the Treatments Tested in This Trial?
Interventions
- Umbilical Cord Clamping at ~120 seconds
- Umbilical Cord Clamping at ~30 seconds
- Umbilical Cord Milking
Umbilical Cord Clamping at ~120 seconds is already approved in United States, European Union for the following indications:
- Prevention of anemia in newborns
- Reduction of need for blood transfusions
- Improvement of iron levels
- Decrease in risk of necrotizing enterocolitis and intraventricular hemorrhage
- Prevention of anemia in newborns
- Reduction of need for blood transfusions
- Improvement of iron levels
- Decrease in risk of necrotizing enterocolitis and intraventricular hemorrhage
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carl Backes, MD
Lead Sponsor
Duke Children's Hospital & Health Center
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Children's Hospital of Philadelphia
Collaborator
University of Bristol
Collaborator
Boston Children's Hospital
Collaborator
Université de Montréal
Collaborator
Emory University
Collaborator
Duke University
Collaborator
The George Washington University Biostatistics Center
Collaborator