Neurodevelopment in Infants With Complex Congenital Heart Defects

Study Overview
=================
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.

Official Title
-----------------
Neurodevelopment in Infants With Complex Congenital Heart Defects

Conditions
-----------------
Complex Congenital Heart Defect

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with Complex Congenital Heart Defect<br>Infants diagnosed a Complex Congenital Heart Defect | |
| Comparison/Healthy Infants<br>Infants born without genetic syndromes or cardiac condition. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MRI (Magnetic Resonance Imaging) of brain - infants with CCHD only | Brain MRI | 1 to 5 days days prior to surgery, 4-10 days after surgery, 6 months of age | 
| Change in Test of Infant Motor Performance (TIMP) | test of early motor development | 0-30 days, 3 months | 
| Change in Mobile Paradigm | Measure of learning, memory, and task-specific kicking coordination in infants | 3 months and 6 months | 
| Change in Heart Rate Variability | Measure of autonomic nervous system function and development | 30 days, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley Scales of Motor Development | 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. | 3 months, 6 months | 
| Edinburgh Postnatal Depression Scale | self report survey to assess maternal depression | 0-30 days, 3 months, 6 months | 
| Infant-Toddler Quality of Life Questionnaire | self report survey to assess infant health status and physical and psychosocial functioning | 0-30 days, 3 months, 6 months | 
| State-Trait Anxiety Inventory | sefl report survey measure of anxiety | 0-30 days, 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complex Congenital Heart Defect, Infants