Neurodevelopment in Infants With Complex Congenital Heart Defects

Complex Congenital Heart Defect Clinical Trial

Official title:

Neurodevelopment in Infants With Complex Congenital Heart Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104751
• Other study ID #: 2015N0040
• Status: Completed
• Start date: June 30, 2016
• Est. completion date: October 24, 2018

Study information

• Verified date: February 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Complex Congenital Heart Defect
• Heart Defects, Congenital

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	American Heart Association, Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Salivary cortisol	Saliva sample to measure snapshot of cortisol release	0-30 days, 3 months, 6 months
Other	Hair cortisol	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	0-30 days, 3 months, 6 months
Other	Fingernail cortisol	Fingernail sample to measure cortisol levels	0-30 days, 3 months, 6 months
Primary	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
Primary	Change in Test of Infant Motor Performance (TIMP)	test of early motor development	0-30 days, 3 months
Primary	Change in Mobile Paradigm	Measure of learning, memory, and task-specific kicking coordination in infants	3 months and 6 months
Primary	Change in Heart Rate Variability	Measure of autonomic nervous system function and development	30 days, 3 months, 6 months
Secondary	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
Secondary	Edinburgh Postnatal Depression Scale	self report survey to assess maternal depression	0-30 days, 3 months, 6 months
Secondary	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
Secondary	State-Trait Anxiety Inventory	sefl report survey measure of anxiety	0-30 days, 3 months, 6 months