Complex Congenital Heart Defect
Conditions
Keywords
Complex Congenital Heart Defect, Infants
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
American Heart Association
Nationwide Children's Hospital
Ohio State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
Yes
Inclusion criteria
* at least 36 weeks gestational age * diagnosed with a Complex Congenital Heart Defect * have at least one English-speaking adult family member
Exclusion criteria
* presence of co-existing, non-cardiac congenital anomalies * ongoing post-operative cardiac pacing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mobile Paradigm | 3 months and 6 months | Measure of learning, memory, and task-specific kicking coordination in infants |
| Change in Test of Infant Motor Performance (TIMP) | 0-30 days, 3 months | test of early motor development |
| Change in Heart Rate Variability | 30 days, 3 months, 6 months | Measure of autonomic nervous system function and development |
| Change in MRI (Magnetic Resonance Imaging) of brain - infants with CCHD only | 1 to 5 days days prior to surgery, 4-10 days after surgery, 6 months of age | Brain MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant-Toddler Quality of Life Questionnaire | 0-30 days, 3 months, 6 months | self report survey to assess infant health status and physical and psychosocial functioning |
| Bayley Scales of Motor Development | 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. |
| Edinburgh Postnatal Depression Scale | 0-30 days, 3 months, 6 months | self report survey to assess maternal depression |
| State-Trait Anxiety Inventory | 0-30 days, 3 months, 6 months | sefl report survey measure of anxiety |
Other
| Measure | Time frame | Description |
|---|---|---|
| Salivary cortisol | 0-30 days, 3 months, 6 months | Saliva sample to measure snapshot of cortisol release |
| Fingernail cortisol | 0-30 days, 3 months, 6 months | Fingernail sample to measure cortisol levels |
| Hair cortisol | 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 |
Countries
United States
Outcome results
None listed