Neurodevelopment in Infants With Complex Congenital Heart Defects

NCT ID: NCT03104751

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-10-24

Brief 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).

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.

Conditions

Complex Congenital Heart Defect

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infants with Complex Congenital Heart Defect

Infants diagnosed a Complex Congenital Heart Defect

No interventions assigned to this group

Comparison/Healthy Infants

Infants born without genetic syndromes or cardiac condition.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Jill Heathcock

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill Heathcock, MPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35190880 (View on PubMed)

Other Identifiers

2015N0040

Identifier Type: -

Identifier Source: org_study_id