Neurodevelopment in Infants With Complex Congenital Heart Defects

February 23, 2021 updated by: Jill Heathcock, Ohio State University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: 0-30 days, 3 months
test of early motor development
0-30 days, 3 months
Change in Mobile Paradigm
Time Frame: 3 months and 6 months
Measure of learning, memory, and task-specific kicking coordination in infants
3 months and 6 months
Change in Heart Rate Variability
Time Frame: 30 days, 3 months, 6 months
Measure of autonomic nervous system function and development
30 days, 3 months, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months, 6 months
Edinburgh Postnatal Depression Scale
Time Frame: 0-30 days, 3 months, 6 months
self report survey to assess maternal depression
0-30 days, 3 months, 6 months
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
0-30 days, 3 months, 6 months
State-Trait Anxiety Inventory
Time Frame: 0-30 days, 3 months, 6 months
sefl report survey measure of anxiety
0-30 days, 3 months, 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Salivary cortisol
Time Frame: 0-30 days, 3 months, 6 months
Saliva sample to measure snapshot of cortisol release
0-30 days, 3 months, 6 months
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
0-30 days, 3 months, 6 months
Fingernail cortisol
Time Frame: 0-30 days, 3 months, 6 months
Fingernail sample to measure cortisol levels
0-30 days, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nationwide Children's Hospital
American Heart Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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