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.
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.
Known fetal chromosomal or genetic abnormalities
Multiple gestation pregnancy
Fetal extra-cardiac anomalies
Single group
Single Arm
Procedure/Surgery* 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.
Neonatal Neurobehavioral Scale
Procedure/SurgeryNeonatal 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.
Pre-operative Neonatal Network Neurobehavioral Scale (NNNS) attention scores
The NeoNatal Neurobehavioral Scale (NNNS-II) examines the neurobehavioral organization, neurological reflexes, motor development - active and passive tone, and signs of stress and withdrawal of the at-risk and drug-exposed infant
Baseline MCA-PI and change in MCA-PI with Maternal Hyperoxia
The fetal middle cerebral artery (MCA) pulsatility index (PI)
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University of Utah
Lead sponsor
Primary Children's Hospital
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
