Neurodevelopment in Infants With Complex Congenital Heart Defects



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:5/23/2018
Start Date:June 30, 2016
End Date:January 30, 2019
Contact:Sarah Landry, MPH
Email:sarah.landry@osumc.edu
Phone:614-366-7638

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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).

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.

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
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Jill Heathcock, MPT, PhD
Phone: 614-355-3623
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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