Clinical Trial: Neurodevelopment in Infants With Complex Congenital Heart Defects

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Neurodevelopment in Infants With Complex Congenital Heart Defects

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 Summary: 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.
Sponsor: Ohio State University

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: March 27, 2017
Date Started: June 30, 2016
Date Completion: June 30, 2018
Last Updated: April 3, 2017
Last Verified: April 2017