Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
University of Utah
Summary
Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design. Pregnant women will be approached during one of their fetal cardiology clinic visits.
Description
Aim 1: Determine the association of baseline cerebrovascular resistance and reactivity and pre-operative neurobehavior in neonates with complex congenital heart disease (CCHD). Exposures: The baseline middle cerebral artery pulsatility index (MCA-PI) and change in MCA-PI. Analyses: Our principal analyses for Aim 1 will use separate linear regression models to relate the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) attention score to 1) the baseline MCA-PI while controlling for maternal age, infant sex, race/ethnicity, and SDOH measures (maternal education, socioeconomic…
Eligibility
- Age range
- 0–52 years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- ProcedureSingle Arm
* Phase 1- Baseline: A fetal echocardiogram will be performed as part of routine standard clinical care. * Phase 2- MH: The participant will be placed on 8 litres of 100% FiO2 (inspired oxygen fraction) via a non-rebreather face mask for 10 minutes. After 10 minutes, additional images will be obtained. MH will be discontinued after additional imaging is complete. * Phase 3- Recovery: After at least 5 minutes of discontinuation of MH, additional images will be obtained to ensure any changes have returned back to baseline.
- ProcedureNeonatal Neurobehavioral Scale
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) evaluation: All neonates with CHD expected to undergo neonatal cardiac intervention or surgery have pre-operative NNNS assessment as PCH as standard of care. The NNNS takes approximately 30 minutes to complete. It is administered by a licensed physical, speech, or occupational therapist who has completed training and additional certification. The NNNS therapist will be blinded to the results of the fetal echocardiogram and MCA-PI.
Locations (5)
- University of California San FranciscoSan Francisco, California
- Children's National Medical CenterWashington D.C., District of Columbia
- Maine Medical CenterScarborough, Maine
- Primary Children's HospitalSalt Lake City, Utah
- University of UtahSalt Lake City, Utah