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Completed

NCT Number: NCT06565299

Cognitive and Speech Disorders in 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

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aleksandra Aeksandrovna Rumiantseva

Kemerovo, Kemerovo Oblast, 650066, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cardiovascular surgery with cardiopulmonary bypass

Procedure

Cardiovascular surgery about congenital heart defects with cardiopulmonary bypass

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kemerovo State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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