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OpenTrials
Completed

NCT Number: NCT03104751

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).

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Key information

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Change in Test of Infant Motor Performance (TIMP)

    Time frame: 0-30 days, 3 months

    test of early motor development

  3. Change in Mobile Paradigm

    Time frame: 3 months and 6 months

    Measure of learning, memory, and task-specific kicking coordination in infants

  4. Change in Heart Rate Variability

    Time frame: 30 days, 3 months, 6 months

    Measure of autonomic nervous system function and development

Secondary outcomes

  1. 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.

  2. Edinburgh Postnatal Depression Scale

    Time frame: 0-30 days, 3 months, 6 months

    self report survey to assess maternal depression

  3. 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

  4. State-Trait Anxiety Inventory

    Time frame: 0-30 days, 3 months, 6 months

    sefl report survey measure of anxiety

Other outcomes

  1. Salivary cortisol

    Time frame: 0-30 days, 3 months, 6 months

    Saliva sample to measure snapshot of cortisol release

  2. Hair cortisol

    Time frame: 0-30 days, 3 months, 6 months

    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

  3. Fingernail cortisol

    Time frame: 0-30 days, 3 months, 6 months

    Fingernail sample to measure cortisol levels

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • American Heart Association
  • Nationwide Children's Hospital

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 7, 2017
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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