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SVR III: Brain Connectome and Neurodevelopmental Outcomes

NCT02692443 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 223

Last updated 2022-05-09

No results posted yet for this study

Summary

Patients with hypoplastic left heart syndrome and other single right ventricle lesions who have undergone the Fontan procedure have a high risk of neurodevelopmental disorders that affect quality of life and adulthood employment. This study will leverage the ongoing National Heart, Lung, and Blood Institute (NHLBI)-funded Single Ventricle Reconstruction Study by using innovative graph measures of brain connectivity to elucidate how alterations of the "connectome" in children with critical congenital heart disease are associated with developmental disabilities and their associated clinical risk factors. Improved understanding of these interrelationships may facilitate development of targeted interventions to improve outcome in the soaring population of adult Fontan survivors.

Conditions

  • Congenital Heart Disease

Interventions

DEVICE

Magnetic Resonance Imaging

Brain MRI without Contrast

BEHAVIORAL

Neurodevelopmental Testing

Validated battery of neurodevelopmental and psychological tests.

Sponsors & Collaborators

Eligibility

Min Age
10 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2022-04-30
Completion
2022-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02692443 on ClinicalTrials.gov