Cognitive and Speech Disorders in Children With Congenital Heart Defects

NCT06565299 | Completed DMC

• 1 other identifier: 6
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

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

Conditions

Cognition Disorder

Keywords

cognitive disoders; heart disease

Outcome Measures

Primary Outcomes (1)

• Neurocognitive status

  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

Study Arms (2)

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

Group 2

without family anamnesis confounding factors

Procedure: Cardiovascular surgery with cardiopulmonary bypass

Interventions

Cardiovascular surgery with cardiopulmonary bypass PROCEDURE

Cardiovascular surgery about congenital heart defects with cardiopulmonary bypass

Group 1; Group 2

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kemerovo State Medical University: lead

Study Sites (1)

Aleksandra Aeksandrovna Rumiantseva

Kemerovo, Kemerovo Oblast, 650066, Russia

Location

MeSH Terms

Conditions

Cognition Disorders; Heart Diseases

Interventions

Cardiovascular Surgical Procedures; Cardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Extracorporeal Circulation

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 21, 2024
• Study Start: March 1, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)