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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Utah
Study ID
NCT05767385
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Complex Congenital Heart Disease
  • Congenital Heart Disease in Children
  • Hypoxia
  • Neurodevelopmental Disorders

Eligibility Criteria

Sex
FEMALE
Age
0 Years - 52 Years
Healthy Volunteers
Not accepted

Interventions

  • Single Arm — PROCEDURE
    * 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
    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.

Study Details

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.

Key Dates

Start date
Dec 17, 2021
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Maternal Hyperoxia (MH) will be administered to pregnant patients after their standard of care fetal echocardiogram has been performed at their scheduled fetal cardiology visit at ³28 weeks gestation. The evaluation at ³28 weeks was chosen since gestational age impacts both the cardiovascular and cerebrovascular response to MH.31 The evaluation will extend the duration of the visit by approximately 30 minutes but additional evaluations or visits for the study will not be required.

Primary Outcome Measure

Pre-operative Neonatal Network Neurobehavioral Scale (NNNS) attention scores [ Time Frame: <=30 days of life ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Shabnam Peyvandi, MD
[email protected]
Children's National Medical CenterWashington D.C.District of Columbia20010
Jennifer Klein, MD
[email protected]
Maine Medical CenterScarboroughMaine04074
Thomas Miller, DO
[email protected]
207-883-5532
Primary Children's HospitalSalt Lake CityUtah84113-
University of UtahSalt Lake CityUtah84132
Lisa M Hansen, BA
[email protected]
801-587-9104
Whitnee Hogan, MD
[email protected]
801-213-3599

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CAChildren's National Medical Center· Washington D.C., DCMaine Medical Center· Scarborough, MEPrimary Children's Hospital· Salt Lake City, UTUniversity of Utah· Salt Lake City, UT

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