500 Participants Needed

Delayed Cord Clamping Techniques for Newborns with Congenital Heart Disease

(CORD-CHD Trial)

Recruiting at 21 trial locations
CB
CE
Overseen ByChelsea E Cobe, BA
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Carl Backes, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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 | Sharp HealthCare

Anup Katheria, MD

Principal Investigator

Sharp Mary Birch Hospital for Women & Newborns

CB

Carl H. Backes, MD

Principal Investigator

Nationwide Children's Hospital

KH

Kevin Hill, MD

Principal Investigator

Duke Children's Hospital

MR

Madeline Rice, PhD

Principal Investigator

George Washington University Biostatistics Center

G(

Grecio (Greg) Sandoval, PhD

Principal Investigator

George Washington University Biostatistics Center

SE

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

My unborn baby has been diagnosed with a heart condition rated 3-6 on the FCDSS.
Singleton gestation
Gestational age at labor and delivery admission (randomization) between 37 0/7 - 41 6/7 weeks of gestation inclusive
See 1 more

Exclusion Criteria

Pregnant individual is a gestational carrier or surrogate
Compromise of the pregnant individual (e.g., vasa previa, placental accreta with hypotension)
Fetal demise or planned termination of pregnancy prior to randomization
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) at birth

Immediate at birth
1 visit (in-person)

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

26 months
Multiple visits (in-person and virtual)

Data Collection

Data collection from electronic medical records for both the mother and infant study participants

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

  • Umbilical Cord Clamping at ~120 seconds
  • Umbilical Cord Clamping at ~30 seconds
  • Umbilical Cord Milking
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Delayed Cord Clamping at 30 Seconds (DCC-30)Active Control1 Intervention
Group II: Delayed Cord Clamping at 120 Seconds (DCC-120)Active Control2 Interventions

Umbilical Cord Clamping at ~120 seconds is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Delayed Umbilical Cord Clamping for:
🇪🇺
Approved in European Union as Delayed Umbilical Cord Clamping for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carl Backes, MD

Lead Sponsor

Trials
1
Recruited
500+

Duke Children's Hospital & Health Center

Collaborator

Trials
1
Recruited
500+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+

University of Bristol

Collaborator

Trials
114
Recruited
25,030,000+

Boston Children's Hospital

Collaborator

Trials
801
Recruited
5,584,000+

Université de Montréal

Collaborator

Trials
223
Recruited
104,000+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

The George Washington University Biostatistics Center

Collaborator

Trials
27
Recruited
111,000+

Published Research Related to This Trial

A survey of 327 healthcare professionals in Malaysia revealed that while most had positive knowledge about the benefits of delayed cord clamping (DCC) for both term and preterm infants, only 29% reported the existence of guidelines on umbilical cord clamping (UCC) at their workplaces.
Despite the awareness of DCC's benefits, such as increasing neonatal iron stores and reducing risks like intraventricular hemorrhage, this knowledge was not consistently applied in practice, highlighting the need for national guidelines to improve UCC practices in childbirth facilities.
A Survey on Current Practices of Umbilical Cord Clamping in Malaysia.Pong, KM., Puasa, N., Mahdy, ZA.[2022]
Delayed cord clamping (DCC) significantly improved hematocrit levels at 72 hours in vigorous neonates born via cesarean section compared to umbilical cord milking (UCM), indicating better placental transfusion benefits.
Despite the hematocrit improvement, there were no significant differences in other clinical outcomes such as serum ferritin, bilirubin levels, or the need for phototherapy between the two groups.
Delayed cord clamping versus cord milking in vigorous neonates ≥35 weeks gestation born via cesarean: A Randomized clinical trial.Murali, M., Sethuraman, G., Vasudevan, J., et al.[2023]
In a study involving 260 preterm infants, umbilical cord milking (UCM) resulted in similar neonatal hemoglobin levels compared to delayed cord clamping (DCC), indicating that UCM is an effective alternative for placental transfusion.
UCM was associated with significantly lower rates of neonatal polycythemia and jaundice compared to DCC, suggesting it may be a safer option for preterm infants requiring resuscitation.
Effect of umbilical cord milking versus delayed cord clamping on preterm neonates in Kenya: A randomized controlled trial.Sura, M., Osoti, A., Gachuno, O., et al.[2021]

Citations

Abstract 14885: Delayed Umbilical Cord Clamping Among ...For ICC, the umbilical cord was clamped immediately (<10 seconds) after birth; for DCC, the cord was clamped 120 seconds after delivery. Results: 24 total ...
Cord Clamping Among Neonates With Congenital Heart ...* Does DCC-120 seconds or DCC-30 seconds after birth lead to better neuromotor outcomes at 22-26 months of infant age (postnatal)?
Delayed Cord Clamping Techniques for Newborns with ...Delayed cord clamping (DCC) significantly benefits newborns by improving hemoglobin levels and reducing the need for blood transfusions, as well as lowering the ...
Timing of umbilical cord clamping among infants with ...The optimal timing of clamping and cutting the umbilical cord at birth among infants with congenital heart disease (CHD) remains a subject of controversy ...
CORD-CHDDoes DCC-120 seconds or DCC-30 seconds after birth lead to better neuromotor outcomes at 22-26 months of infant age (postnatal)?. Participants will be asked to ...
A Simple Intervention With Great PotentialThe randomized trial will compare the impact of a standard 30-second clamp vs a delay of 120 seconds. The extra blood that transfers from the ...
Cord Clamping Among Neonates With Congenital Heart ...Care team will wait to clamp the umbilical cord between 60-180 seconds after birth.120 seconds is the ideal time of clamping.
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