Cognitive and Speech Disorders in Children With Congenital Heart Defects

August 20, 2024 updated by: Evgeny Grigoryev, Kemerovo State Medical University

Cognitive and Speech Disorders in 5-7 Years Old Children With Congenital Heart Defects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Kuzbass
      • Kemerovo, Kuzbass, Russian Federation, 650066
        • Aleksandra Aeksandrovna Rumiantseva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

5-7 years old children with congenital heart defects bofore abd after cardiovascular operation with cardiopulmonary bypass

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Procedure: Cardiovascular surgery with cardiopulmonary bypass
Cardiovascular surgery about congenital heart defects with cardiopulmonary bypass
Group 2
without family anamnesis confounding factors
Procedure: Cardiovascular surgery with cardiopulmonary bypass
Cardiovascular surgery about congenital heart defects with cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive status
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kemerovo State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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