Understanding fetal brain blood flow in babies with heart defects
Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
PHASE2; PHASE3 · University of Utah · NCT05767385
This study is trying to see how abnormal blood flow in the brain of unborn babies with heart defects affects their development after birth.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 0 Years to 52 Years |
| Sex | Female |
| Sponsor | University of Utah (other) |
| Locations | 5 sites (San Francisco, California and 4 other locations) |
| Trial ID | NCT05767385 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate how abnormal blood flow in the fetal brain affects neurodevelopmental outcomes in newborns with complex congenital heart disease (CCHD). It will assess the relationship between cerebrovascular resistance and neonatal neurobehavior, considering various factors such as maternal health and social determinants. Pregnant women with a singleton fetus diagnosed with CCHD will be recruited during fetal cardiology visits, and their infants' neurobehavior will be evaluated using the Neonatal Intensive Care Unit Network Neurobehavioral Scale. The study employs a multicenter design to gather diverse data.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older with a singleton fetus diagnosed with congenital heart disease requiring intervention shortly after birth.
Not a fit: Patients with known fetal chromosomal or genetic abnormalities, multiple gestation pregnancies, or extra-cardiac anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and interventions for neurodevelopmental delays in infants with congenital heart disease.
How similar studies have performed: Other studies have explored similar relationships between fetal physiology and neurodevelopment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women 18 years of age and over with a singleton fetus with known or suspected congenital heart disease anticipated to need intervention or surgery within 30 days of birth. Exclusion Criteria: * Known fetal chromosomal or genetic abnormalities * Multiple gestation pregnancy * Fetal extra-cardiac anomalies
Where this trial is running
San Francisco, California and 4 other locations
- University of California San Francisco — San Francisco, California, United States (NOT_YET_RECRUITING)
- Children's National Medical Center — Washington D.C., District of Columbia, United States (NOT_YET_RECRUITING)
- Maine Medical Center — Scarborough, Maine, United States (NOT_YET_RECRUITING)
- Primary Children's Hospital — Salt Lake City, Utah, United States (NOT_YET_RECRUITING)
- University of Utah — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Study coordinator: Whitnee Hogan, MD
- Email: whitnee.hogan@hsc.utah.edu
- Phone: 801-213-3599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease in Children, Hypoxia, Neurodevelopmental Disorders, Complex Congenital Heart Disease, Congenital Heart Disease, Maternal Fetal, Neonatal Neurodevelopment