Cognitive and Speech Disorders in Children With Congenital Heart Defects

Completed

• Conditions: Cognition Disorder

• Registration Number: NCT06565299
• Lead Sponsor: Kemerovo State Medical University

Brief Summary

The study is aimed to found out expressive speech disorders as a sign of neurocognitive development delay in children with congenital heart defects before and after surgery

Detailed Description

The study will investigate the influence of congenital heart disease, operation and other health factors on neurocognitive and speech status of 5-7 years old children

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2024-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• children with congenital heart disease that required total correction using cardiopulmonary bypass

Exclusion Criteria

• patients with heart disease requiring palliative or endovascular correction, as well as children with chromosomal and genetic diseases (determined by karyotyping)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurocognitive status	2 years	Monitoring before the cardiovascular operation and in postoperative period (in 1 and 2 years).; Assessment of speech disorders, short-term and long-term memory impairments.

Trial Locations

Locations (1)

Aleksandra Aeksandrovna Rumiantseva; 🇷🇺 Kemerovo, Kuzbass, Russian Federation