Neurodevelopment in Infants With Complex Congenital Heart Defects

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).

Study Overview

• Status: Completed
• Conditions: Complex Congenital Heart Defect

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants are infants born with a complex congenital heart defect.Cardiac defects include, but are not be limited to: atrioventricular canal defect, double outlet right ventricle, hypoplastic left heart syndrome, interrupted aortic arch, pulmonary atresia, tetralogy of Fallot, and transposition of the great arteries.All participants are recruited from Nationwide Children's Hospital in Columbus, OH. Healthy infants will also be enrolled as a comparison group.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Infants with Complex Congenital Heart Defect; Infants diagnosed a Complex Congenital Heart Defect
Comparison/Healthy Infants; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary cortisol	Saliva sample to measure snapshot of cortisol release	0-30 days, 3 months, 6 months
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
Fingernail cortisol	Fingernail sample to measure cortisol levels	0-30 days, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Nationwide Children's Hospital; American Heart Association

Publications and helpful links

General Publications

• Tripathi T, Harrison TM, Simsic JM, Cabral TI, Heathcock JC. Screening and Evaluation of Neurodevelopmental Impairments in Infants Under 6 Months of Age with Congenital Heart Disease. Pediatr Cardiol. 2022 Mar;43(3):489-496. doi: 10.1007/s00246-021-02745-4. Epub 2022 Feb 21.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2016
• Primary Completion (ACTUAL): October 24, 2018
• Study Completion (ACTUAL): October 24, 2018

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (ACTUAL): April 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Infants; Complex Congenital Heart Defect
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: 2015N0040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No