Cord Clamping Among Neonates with Congenital Heart Disease
- Conditions
- Congenital Heart Disease (CHD)
- Interventions
- Procedure: Umbilical Cord Clamping at ~120 secondsProcedure: Umbilical Cord Clamping at ~30 secondsProcedure: Umbilical Cord Milking
- Registration Number
- NCT06153459
- Lead Sponsor
- Carl Backes, MD
- Brief Summary
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.
- Detailed Description
* AIM 1: Test the hypothesis that, among neonates with prenatally diagnosed significant CHD (ranking of 3 - 6 on the Fetal Cardiovascular Disease Severity Score \[FCDSS\]), DCC-120 results in lower global rank score (GRS), indicative of better health outcomes, compared with DCC-30.
* AIM 2: Test the hypothesis that, among neonates with prenatally diagnosed significant CHD (ranking from 3 - 6 on the Fetal Cardiovascular Disease Severity Score \[FCDSS\]), DCC-120 will result in better neuromotor outcomes at 22-26 months postnatal than DCC-30.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
- Fetal demise or planned termination of pregnancy prior to randomization
- Tachyarrhythmia requiring transplacental therapy
- Fetal hydrops, severe
- Planned fetal surgery
- Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
- Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed
- Disease or disorder impacting candidacy for neonatal cardiac interventions
- Parents choosing to limit treatment
Pregnancy Exclusion Criteria:
- Delivery planned at an institution not affiliated with or does not refer to a CORD-CHD participating site
- Participation in another prenatal interventional study that influences cord clamping or perinatal morbidity or mortality
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed Cord Clamping at 120 Seconds (DCC-120) Umbilical Cord Clamping at ~120 seconds 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. Delayed Cord Clamping at 30 Seconds (DCC-30) Umbilical Cord Clamping at ~30 seconds The umbilical cord will be clamped between 1 - \<60 seconds following delivery, with a goal of around 30 seconds. Delayed Cord Clamping at 120 Seconds (DCC-120) Umbilical Cord Milking 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.
- Primary Outcome Measures
Name Time Method Global Rank Score (Infant participant) Up to 30 days post-discharge following congenital heart disease intervention Mortality=97; Heart transplant=96; Complication preventing cardiac intervention=95; Post-intervention neurologic complication=95; Post-intervention respiratory failure w/tracheostomy=95; Renal failure permanent dialysis=95; Unplanned cardiac surgery after initial cardiac intervention=94; Cardiac arrest=94; Post-intervention multisystem organ failure=94; Mechanical circulatory support=94; Pre-intervention polycythemia w/exchange transfusion/hemodilution=93; Unplanned cardiac catheterization after initial cardiac intervention=93; Pre-intervention mechanical ventilation=93; Pre-intervention necrotizing enterocolitis(Bell's II/III)=93; Pre-intervention shock=93; Pre-intervention unplanned hospitalization=93; Post-intervention bleeding reoperation=93; Delayed sternal closure=93; Pre-intervention renal failure temporary dialysis=93; Post-intervention renal failure, temporary dialysis=92; Post-intervention mechanical ventilation \>7 days=92; Hospital length of stay \>90 days=91, 1-90 days=1-90
- Secondary Outcome Measures
Name Time Method Neuromotor Outcomes at 3-4 months of age (Infant participant) 3-4 months after birth General Movements Assessment (GMA): The General Movements Assessment is used to identify absent or abnormal general movements in infants. General movements are spontaneous movements exhibited during fetal development and through the first 6 months of life after birth. Trained investigators will evaluate the infants general movements as: 1) Fidgety present; 2) Fidgety abnormal; and 3) Absent fidgety where "Fidgety present" is considered normal, and the other two outcomes are considered abnormal.
Parental perspectives of outcomes (Parents / Caregivers) 22-26 months after birth Survey of parent / caregiver opinions of expectations and outcomes as it relates to their infant with congenital heart disease. This questionnaire will examine parental perspectives with regards to health and neurodevelopmental outcomes, as compared to those commonly used in pediatric medicine. For example, parents / caregivers may place greater emphasis upon their child being able to conduct physical activity as compared to how well they perform tasks (fine and gross neuromotor function). Additionally, parents may express concern for their infant being able to eat without requiring a feeding tube, or breathing without the need for assistance or additional oxygen support. The survey will also seek to determine areas in which parents / caregivers feel there is room for improvement as it applies to their infant. There is no formal "scale" for this survey, as responses are primarily open-ended, requiring descriptive content analysis.
Impact of infant's congenital heart disease (Parents / Caregivers) 22-26 months after birth Questionnaire/Survey on the impact of infant's congenital heart disease upon the family dynamic; Functional Status II - Revised, Short Form: The Functional Status II - Revised, Short Form will be used to evaluate the functional status of infants that have been diagnosed with and undergone treatment for congenital heart disease. This survey, completed by parents / caregivers, is used to evaluate a core of 14 items using a 3-point Likert scale. The respondent (parent) first rates the extent of difficulty with specific behaviors that the infant experiences, and then rates for those behaviors with difficulty, the extent to which the difficulty is due to the infants chronic illness. Higher scores generally indicate a reduced burden of chronic heart disease impacting the family, and therefore, a better outcome.
Neurodevelopmental Outcomes at 22-26 months (Infant participant) 22-26 months after birth Developmental Assessment of Young Children, 2nd Edition (DAYC-2): The Developmental Assessment of Young Children, Second Edition (DAYC-2) is used to evaluate infants and children over 5 domains: cognition; communication; social-emotional development; physical development; and adaptive behavior. The DAYC-2 uses a norm-referenced sample to establish standardized scores in each domain, allowing investigators to compare the results to infants of similar age. Percentile ranks, and age equivalents are provided for each domain. Elements are graded on a simple "Yes" or "No" scale, with "Yes" being 1 point and "No" being 0 points. In general, higher scores reflect better expected outcomes.
Delivery Complications and Outcomes (Pregnant individual participant) Through hospital discharge (up to 1 month) Incidence of mortality
Trial Locations
- Locations (21)
Children's of Alabama
🇺🇸Birmingham, Alabama, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Lucile Packard Children's Hospital Stanford
🇺🇸Palo Alto, California, United States
Sharp Mary Birch Hospital for Woman and Newborns
🇺🇸San Diego, California, United States
UF Health Shands Children's Hospital
🇺🇸Gainesville, Florida, United States
Johns Hopkins Children's Center
🇺🇸Baltimore, Maryland, United States
Children's of Mississippi
🇺🇸Jackson, Mississippi, United States
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
SSM Health Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Duke Children's Hospital & Health Center
🇺🇸Durham, North Carolina, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Columbia, South Carolina, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Stollery Children's Hospital, University of Alberta
🇨🇦Edmonton, Alberta, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada