Cognitive and Speech Disorders in Children With Congenital Heart Defects

NCT ID: NCT06565299

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2024-08-01

Brief Summary

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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

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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

Conditions

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Cognition Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Children with family anamnesis confounding factorss, such as family composition, living conditions, conflict families (members of family suffering from any type of addiction, prisoned members of family, conflicts in front of a child's eyes).

Cardiovascular surgery with cardiopulmonary bypass

Intervention Type PROCEDURE

Cardiovascular surgery about congenital heart defects with cardiopulmonary bypass

Group 2

without family anamnesis confounding factors

Cardiovascular surgery with cardiopulmonary bypass

Intervention Type PROCEDURE

Cardiovascular surgery about congenital heart defects with cardiopulmonary bypass

Interventions

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Cardiovascular surgery with cardiopulmonary bypass

Cardiovascular surgery about congenital heart defects with cardiopulmonary bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kemerovo State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Evgeny Grigoryev

Head of the Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aleksandra Aeksandrovna Rumiantseva

Kemerovo, Kemerovo Oblast, Russia

Site Status

Countries

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Russia

Other Identifiers

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6

Identifier Type: -

Identifier Source: org_study_id

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