Cord Clamping Among Neonates With Congenital Heart Disease
ConditionCongenital Heart Disease (CHD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age37-42
SponsorCarl Backes, MD
About 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.
Eligibility criteria
Qualifiers
Fetal diagnosis of congenital heart disease (CHD) by prenatal ultrasound / echocardiography from local fetal ECHO, conducted on or after 18 weeks of gestation and prior to randomization. The study fetal diagnosis of CHD must be rated as 3 - 6 on the Fetal Cardiovascular Disease Severity Score (FCDSS), as determined by independent evaluators at the CORD-CHD trial ECHO Core at the Children's Hospital of Philadelphia (to determine final FCDSS eligibility for randomization).
Singleton gestation.
Gestational age at randomization for impending deliveries between 37 0/7 - 41 6/7 weeks of gestation inclusive based on clinical information and evaluation of the earliest ultrasound determined using criteria proposed by the American Congress of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine and the Society for Maternal-Fetal Medicine.
Consent for the participant and their infant
Disqualifiers
Pregnant individual is a gestational carrier or surrogate.
Compromise of the pregnant individual (e.g., vasa previa, placental accreta with hypotension, placental abruption, amniotic fluid embolism, uterine rupture, uterine inversion, disseminated intravascular coagulation), as determined by local care team
Fetal demise or planned termination of pregnancy prior to randomization
Tachyarrhythmia requiring transplacental therapy
Trial design
Treatments tested in this trial
- Umbilical Cord Clamping at ~30 seconds
- Umbilical Cord Clamping at ~120 seconds
- Umbilical Cord Milking
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Carl Backes, MD
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
The George Washington University Biostatistics Center
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Emory University
Collaborator
Boston Children's Hospital
Collaborator
University of Bristol
Collaborator
Geisinger Commonwealth School of Medicine
Collaborator
Duke University
Collaborator
Children's Hospital of Philadelphia
Collaborator
Sharp Mary Birch Hospital for Women & Newborns
Collaborator
Université de Montréal
Collaborator
Source ClinicalTrials.gov