150
Participants
Start Date
December 17, 2021
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
Single 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."
Neonatal 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.
NOT_YET_RECRUITING
Children's National Medical Center, Washington D.C.
NOT_YET_RECRUITING
Primary Children's Hospital, Salt Lake City
RECRUITING
University of Utah, Salt Lake City
NOT_YET_RECRUITING
University of California San Francisco, San Francisco
NOT_YET_RECRUITING
Maine Medical Center, Scarborough
Primary Children's Hospital
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Utah
OTHER