Actively Recruiting
Led by University of Utah · Updated on 2025-06-25
150
Participants Needed
5
Research Sites
N/A
Total Duration
U
University of Utah
Lead Sponsor
P
Primary Children's Hospital
Collaborating Sponsor
Researchers are investigating how abnormal blood flow regulation in the brains of fetuses with complex congenital heart disease (CCHD) relates to delays in neurodevelopment. The study also looks at how this relationship is influenced by patient factors like the type of heart defect, maternal-fetal environment, and social determinants of health in a diverse group of pregnant women. This study uses data from multiple centers and approaches pregnant women during their fetal cardiology visits. The study involves a single treatment group where pregnant women receive maternal hyperoxia (MH) therapy at around 28 weeks gestation during their scheduled fetal echocardiogram. MH involves breathing 100% oxygen through a face mask for 10 minutes, with imaging taken before, during, and after this oxygen exposure to observe changes in the fetal brain's blood flow. Following birth, neonates with congenital heart disease undergo a pre-operative neurobehavioral assessment using the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS). Participants will have their fetal brain blood flow measured via ultrasound at baseline, during MH, and after recovery. After birth, the neurobehavioral scale will be administered by certified therapists to evaluate attention and related functions within 30 days of life. Researchers will collect detailed patient and environmental information to analyze how these factors affect brain blood flow and neurodevelopment. The total study period includes prenatal evaluation and neonatal assessment within the first month of life, with no additional visits required beyond routine care.
CONDITIONS
Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit lasting approximately 30 minutes longer than standard fetal cardiology visit
Participants undergo a fetal echocardiogram followed by maternal hyperoxia (MH) where 8 litres of 100% oxygen is given via a non-rebreather face mask for 10 minutes, with imaging before, during, and after MH administration to assess cerebrovascular response.
1 visit (in-person)
Duration - Assessment occurs within 30 days of birth
After birth, neonates with congenital heart disease receive a pre-operative Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) evaluation to assess neurobehavioral function before surgery.
1 visit (in-person)
Total: 5 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
3
Maine Medical Center
Scarborough, Maine, United States, 04074
Not Yet Recruiting
4
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Not Yet Recruiting
5
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
W
Whitnee Hogan, MD
L
Lisa M. Hansen, BA
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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