Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

December 17, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Congenital Heart Disease in ChildrenHypoxiaNeurodevelopmental DisordersComplex Congenital Heart Disease
Interventions
PROCEDURE

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."

PROCEDURE

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.

Trial Locations (5)

20010

NOT_YET_RECRUITING

Children's National Medical Center, Washington D.C.

84113

NOT_YET_RECRUITING

Primary Children's Hospital, Salt Lake City

84132

RECRUITING

University of Utah, Salt Lake City

94143

NOT_YET_RECRUITING

University of California San Francisco, San Francisco

04074

NOT_YET_RECRUITING

Maine Medical Center, Scarborough

All Listed Sponsors
collaborator

Primary Children's Hospital

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Utah

OTHER