Umbilical Cord Clamping at ~30 secondsUmbilical Cord Clamping at ~120 secondsUmbilical Cord Milking
Umbilical Cord Clamping at ~30 seconds: Care team will wait to clamp the umbilical between 1-\<60 seconds after birth. 30 seconds is the ideal time of clamping.
Umbilical Cord Clamping at ~120 seconds: Care team will wait to clamp the umbilical cord between 60-180 seconds after birth.120 seconds is the ideal time of clamping
Umbilical Cord Milking: For infants who need their cord clamped before the target in the DCC-120 group. Care team may milk the umbilical cord towards the infant four times. Cord milking should NOT be performed if the delay meets or exceeds 60 seconds.
Umbilical cord milking will not be provided among participant-infant dyads in the DCC-30 group.
Study 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.
Eligibility
Sex
ALL
Min age
37 Weeks
Max age
42 Weeks
Healthy volunteers
No
Inclusion criteria are listed below and will be confirmed prior to randomization:
1. 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).
For each potential participant that has provided consent, the most relevant diagnostic prenatal ultrasound will be uploaded (shared) between 32 weeks of gestation and randomization for review by the ECHO Core. The ECHO Core will make the final FCDSS determination for eligibility status and stratification assignment.\]
\[NOTE: A fetal diagnosis of CHD rated as 3 - 6 FCDSS per local review, including borderline cases, will be used to determine preliminary eligibility for consent. Among borderline cases, eligible patients will be included if there is a reasonable expectation of the need for surgery or cardiac catheterization during the birth hospitalization.\]
2. Singleton gestation.
3. 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.
\[NOTE: Pregnant individuals who were admitted to the delivery hospital prior to 37 0/7 weeks of gestation remain eligible to randomize, provided they deliver within the 37 0/7 and 41 6/7 weeks "eligibility window". Alternatively, if an eligible dyad is randomized at or just prior to 41 6/7 weeks, they remain in trial.\]
4. Consent for the participant and their infant
Exclusion criteria are listed below and will be confirmed prior to randomization:
Exclusion Criteria for Pregnant Individuals:
1. Pregnant individual is a gestational carrier or surrogate.
2. 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
\[NOTE: There is no limitation on pregnant individual's age\]
Fetal Exclusion Criteria:
1. Fetal demise or planned termination of pregnancy prior to randomization
2. Tachyarrhythmia requiring transplacental therapy
3. Fetal hydrops, severe
4. Planned fetal surgery
5. Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
6. Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed
7. Disease or disorder impacting candidacy for neonatal cardiac interventions
8. Parents choosing to limit treatment
Pregnancy Exclusion Criteria:
1. Delivery planned at an institution not affiliated with or does not refer to a CORD-CHD participating site
2. Participation in another prenatal interventional study that influences cord clamping or perinatal morbidity or mortality
Primary outcome measure(s)
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;Pre or Post-intervention neurologic complication=95;Pre or Post-intervention respiratory failure w/tracheostomy=95;Renal failure permanent dialysis=95;Unplanned cardiac surgery after initial cardiac intervention=94;Cardiac arrest=94;Pre or 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
Trial sites (21)
Facility
City
Region
Status
Children's of Alabama
Birmingham
Alabama
Recruiting
Cedars-Sinai Medical Center
Los Angeles
California
Recruiting
Children's Hospital of Orange County
Orange
California
Not Yet Recruiting
Lucile Packard Children's Hospital Stanford
Palo Alto
California
Not Yet Recruiting
Sharp Mary Birch Hospital for Woman and Newborns
San Diego
California
Recruiting
UF Health Shands Children's Hospital
Gainesville
Florida
Recruiting
Johns Hopkins Children's Center
Baltimore
Maryland
Recruiting
Children's of Mississippi
Jackson
Mississippi
Recruiting
The Children's Mercy Hospital
Kansas City
Missouri
Recruiting
SSM Health Cardinal Glennon Children's Hospital
St Louis
Missouri
Recruiting
Duke Children's Hospital & Health Center
Durham
North Carolina
Recruiting
Nationwide Children's Hospital
Columbus
Ohio
Recruiting
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Recruiting
Medical University of South Carolina
Columbia
South Carolina
Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville
Tennessee
Recruiting
Texas Children's Hospital
Houston
Texas
Recruiting
University of Texas Health Science Center at San Antonio
San Antonio
Texas
Recruiting
Primary Children's Hospital
Salt Lake City
Utah
Recruiting
Stollery Children's Hospital, University of Alberta
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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