Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
NCT Number: NCT03104751
The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with Complex Congenital Heart Disease (CCHD).
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All sexes
Observational
Columbus, Ohio, 43205, United States
The investigators' long-term goals are to develop a method of identifying infants likely to have adverse neurodevelopmental outcomes following neonatal treatment for CCHD and to develop and test interventions that can be applied early in infancy. The necessary first step is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with CCHD. Each measure provides unique information about development and will include (1) neuroimaging for brain maturity and brain injury, (2) hair and fingernails for cortisol and saliva for immune system function, (3) heart rate variability (HRV) for autonomic nervous system function (ANS), (4) Bayley Scales of Infant Development (BSID-III) for cognitive and motor function, (5) a naturalistic play session incorporating kicking, general movement analysis, or the Test of Infant Motor Performance (TIMP) for motor development, and (6) the mobile paradigm for learning, memory, and task-specific coordination. The investigators will look at types of relationships among these measures within each time point for description of development and across each time point for prediction of development. The investigators' core hypotheses are that infants with CCHD will have measurable deficits in cognitive and motor development birth to ~ 6 months of age when compared with a healthy control group and that a typology developed from neurodevelopmental measures will reliably predict cognitive and motor delay in the first six months of life in infants with CCHD.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 to 5 days days prior to surgery, 4-10 days after surgery, 6 months of age
Brain MRI
Time frame: 0-30 days, 3 months
test of early motor development
Time frame: 3 months and 6 months
Measure of learning, memory, and task-specific kicking coordination in infants
Time frame: 30 days, 3 months, 6 months
Measure of autonomic nervous system function and development
Time frame: 3 months, 6 months
The Bayley Scales of Infant and Toddler Development is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior.
Time frame: 0-30 days, 3 months, 6 months
self report survey to assess maternal depression
Time frame: 0-30 days, 3 months, 6 months
self report survey to assess infant health status and physical and psychosocial functioning
Time frame: 0-30 days, 3 months, 6 months
sefl report survey measure of anxiety
Time frame: 0-30 days, 3 months, 6 months
Saliva sample to measure snapshot of cortisol release
Time frame: 0-30 days, 3 months, 6 months
Hair cortisol provides a validated measure of intensity and course of stress exposure over time and is considered a proxy measure of total HPA activation
Time frame: 0-30 days, 3 months, 6 months
Fingernail sample to measure cortisol levels
Ohio State University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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