Delayed Cord Clamping Techniques for Newborns with Congenital Heart Disease
(CORD-CHD Trial)
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Carl Backes, MD
Disqualifiers: Gestational carrier, Fetal demise, Tachyarrhythmia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD). The main questions it aims to answer are:
* Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) after birth lead to better health outcomes?
* Does 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 do the following:
* Participate in either DCC-120 or DCC-30 at birth (randomized assignment).
* Complete General Movements Assessment (GMA) at 3-4 months of infant age (postnatal), complete questionnaires / surveys at this time.
* Complete questionnaires / surveys at 9-12 months of infant age (postnatal).
* Complete Hammersmith Infant Neurological Examination (HINE), Developmental Assessment of Young Children 2 Edition (DAYC-2), and questionnaires / surveys at 22-26 months of infant age (postnatal).
* Permit data collection from electronic medical records for both the mother and infant study participants.
Investigators will compare DCC-120 vs. DCC-30 to see which approach is more beneficial to both the mother and baby with CHD.
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 data supports the effectiveness of the treatment Delayed Cord Clamping Techniques for Newborns with Congenital Heart Disease?
Research shows that delayed cord clamping (waiting before cutting the umbilical cord) can increase hemoglobin levels, reduce the need for blood transfusions, and lower the risk of certain complications in newborns, such as brain bleeding and gut issues. These benefits have been observed in both preterm and full-term infants, suggesting potential advantages for newborns with congenital heart disease as well.
12345Is delayed cord clamping safe for newborns?
Delayed cord clamping (DCC) is generally considered safe and may offer health benefits for newborns, including those with congenital heart disease, as well as preterm infants. Studies have shown that DCC can improve neonatal health without apparent safety issues, even in cesarean births and preterm infants.
23467How does the treatment of delayed cord clamping differ from other treatments for newborns with congenital heart disease?
Delayed cord clamping (DCC) involves waiting longer before clamping the umbilical cord, allowing more blood to transfer from the placenta to the newborn, which may improve health outcomes. This approach is unique because it focuses on enhancing blood volume and oxygenation in newborns with congenital heart disease, unlike immediate clamping or other interventions that do not utilize this natural transfusion process.
23468Eligibility Criteria
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
+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
+10 more
Trial Timeline
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
Participant Groups
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.
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.
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:
- Prevention of anemia in newborns
- Reduction of need for blood transfusions
- Improvement of iron levels
- Decrease in risk of necrotizing enterocolitis and intraventricular hemorrhage
🇪🇺 Approved in European Union as Delayed Umbilical Cord Clamping for:
- 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
Research Locations NearbySelect from list below to view details:
IWK Health CentreHalifax, Canada
Cedars-Sinai Medical CenterLos Angeles, CA
UF Health Shands Children's HospitalGainesville, FL
Medical University of South CarolinaColumbia, SC
More Trial Locations
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Who Is Running the Clinical Trial?
Carl Backes, MDLead Sponsor
Duke Children's Hospital & Health CenterCollaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
Children's Hospital of PhiladelphiaCollaborator
University of BristolCollaborator
Boston Children's HospitalCollaborator
Université de MontréalCollaborator
Emory UniversityCollaborator
Duke UniversityCollaborator
The George Washington University Biostatistics CenterCollaborator
References
A Quality Improvement Project to Delay Umbilical Cord Clamping Time. [2022]Delayed cord clamping (DCC) has numerous benefits to the neonate, including increased hemoglobin levels, decreased need for red blood cell transfusions, and decreased incidence of necrotizing enterocolitis and intraventricular hemorrhage. A preliminary observational study at our institution demonstrated 12% of the observed deliveries met the DCC standard, defined as umbilical cord clamping at least 30-60 seconds after birth. Therefore, we designed a quality improvement project to increase the percentage of deliveries using DCC.
Effect of umbilical cord milking versus delayed cord clamping on preterm neonates in Kenya: A randomized controlled trial. [2021]Delayed cord clamping (DCC) is a placental to new-born transfusion strategy recommended by obstetric and gynaecological societies. Though not widely adopted, umbilical cord milking (UCM) may achieve faster transfusion when DCC cannot be performed such as when a neonate requires resuscitation.
A Survey on Current Practices of Umbilical Cord Clamping in Malaysia. [2022]Delayed cord clamping (DCC) has been demonstrated to have significant benefits in reducing the incidence of intraventricular hemorrhage, blood transfusion and neonatal mortality in preterm neonates and improving hemodynamic and long-term neurodevelopment among term infants. There is no clear guideline on umbilical cord clamping (UCC) practices in Malaysia.
Implementing Delayed Umbilical Cord Clamping in Cesarean Birth Using a Novel Method: A Pilot Study of Feasibility and Safety. [2021]Although delayed cord clamping (DCC) is regarded as the standard of care for all vigorous newborns, those born via cesarean birth are less likely to be afforded this option, especially for longer than 30 to 60 seconds. This pilot study was undertaken to determine whether removal of the placenta before cord clamping to allow for DCC of at least 3 minutes during term, uncomplicated cesarean birth is feasible and without apparent safety issues in order to support a large prospective study on the benefits of this method.
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial. [2020]The American College of Obstetricians and Gynecologists recommends a delay in umbilical cord clamping in term neonates for at least 30 to 60 seconds after birth. Most literature supporting this practice is from low-risk vaginal deliveries. There are no published data specific to cesarean delivery.
Early versus delayed umbilical cord clamping in infants with congenital heart disease: a pilot, randomized, controlled trial. [2018]Delayed umbilical cord clamping (DCC) at birth may provide a better neonatal health status than early umbilical cord clamping (ECC). However, the safety and feasibility of DCC in infants with congenital heart disease (CHD) have not been tested. This was a pilot, randomized, controlled trial to establish the safety and feasibility of DCC in neonates with CHD.
Safety of delayed umbilical cord clamping in preterm neonates of less than 34 weeks of gestation: a randomized controlled trial. [2022]There is concern regarding the safety of delayed cord clamping (DCC) in babies born at less than 34 weeks' gestation. Therefore, the primary objective of this study was to compare the rates of hyperbilirubinemia and polycythemia during initial 7 days in infants born at less than 34 weeks' gestation and randomized to receive DCC by 120 seconds or early cord clamping (ECC) within less than 30 seconds.
Delayed cord clamping versus cord milking in vigorous neonates ≥35 weeks gestation born via cesarean: A Randomized clinical trial. [2023]Delayed cord clamping (DCC) is the recommended strategy in neonates not requiring resuscitation, but umbilical cord milking (UCM) can also be used in term babies. DCC has been found to offer advantages more than just placental transfusion.