Neurodevelopment in Infants With Complex Congenital Heart Defects

NCT03104751 | Completed

• 1 other identifier: 2015N0040
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Complex Congenital Heart Defect

Keywords

Complex Congenital Heart Defect; Infants

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Bayley Scales of Motor Development

  3 months, 6 months

• Edinburgh Postnatal Depression Scale

  0-30 days, 3 months, 6 months

• Infant-Toddler Quality of Life Questionnaire

  0-30 days, 3 months, 6 months

• State-Trait Anxiety Inventory

  0-30 days, 3 months, 6 months

Other Outcomes (3)

• Salivary cortisol

  0-30 days, 3 months, 6 months

• Hair cortisol

  0-30 days, 3 months, 6 months

• Fingernail cortisol

  0-30 days, 3 months, 6 months

Study Arms (2)

Infants with Complex Congenital Heart Defect

Infants diagnosed a Complex Congenital Heart Defect

Comparison/Healthy Infants

Infants born without genetic syndromes or cardiac condition.

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• at least 36 weeks gestational age
• diagnosed with a Complex Congenital Heart Defect
• have at least one English-speaking adult family member

You may not qualify if:

• presence of co-existing, non-cardiac congenital anomalies
• ongoing post-operative cardiac pacing

Sponsors & Collaborators

• Ohio State University: lead
• American Heart Association: collaborator
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 35190880 DERIVED

Study Officials

• Jill Heathcock, MPT, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 7, 2017
• Study Start: June 30, 2016
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

US (1)