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New treatment option for Congenital Heart Disease (CHD)
Official title Cord Clamping Among Neonates With Congenital Heart Disease
ClinicalTrials.gov ID: NCT06153459
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 37 to 42
You may be able to join if
- are listed below and will be confirmed prior to randomization:
- Fetal diagnosis of congenital heart disease (CHD) by prenatal ultrasound / echocardiography from local fetal ECHO, conducted on or after 18 weeks of...
- 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...
- Consent for the participant and their infant
You likely can't join if
- are listed below and will be confirmed prior to randomization: Exclusion Criteria for Pregnant Individuals:
- 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...
- Fetal demise or planned termination of pregnancy prior to randomization
- Tachyarrhythmia requiring transplacental therapy
- Fetal hydrops, severe
See the full eligibility criteria
- are listed below and will be confirmed prior to randomization:
- 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...
- 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...
- Consent for the participant and their infant
- are listed below and will be confirmed prior to randomization: Exclusion Criteria for Pregnant Individuals:
- 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...
- 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 treatment study that influences cord clamping or perinatal morbidity or mortality
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- Gainesville, Florida, United States
- Baltimore, Maryland, United States
- Jackson, Mississippi, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Columbia, South Carolina, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- Edmonton, Alberta, Canada
- Halifax, Nova Scotia, Canada
+ 1 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 37 weeks to 42 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; San Diego, California, United States; Gainesville, Florida, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.