Cognition DisorderNCT06565299
Cognitive and Speech Disorders in Children With Congenital Heart Defects
An observational study of Cognition Disorder, run by Kemerovo State Medical University at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Cognition Disorder
- What is being tested?
- Cardiovascular surgery with cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- How many people
- 217 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2019to 1 Aug 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: 5-7 years old children with congenital heart defects bofore abd after cardiovascular operation with cardiopulmonary bypass
Who may be able to join
- children with congenital heart disease that required total correction using cardiopulmonary bypass
Who cannot join
- patients with heart disease requiring palliative or endovascular correction, as well as children with chromosomal and genetic diseases (determined by karyotyping)
Trial locations and contacts
1 site in 1 country.
Russia1 site
Aleksandra Aeksandrovna Rumiantseva
Kemerovo, Kemerovo Oblast, 650066
About this study
Official title: 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
Read the 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
- Conditions
- Cognition Disorder
- Being tested
- Cardiovascular surgery with cardiopulmonary bypass
- Keywords
- cognitive disoders, heart disease
- Medical subject headings
- Cognition Disorders, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular surgery with cardiopulmonary bypassProcedure or surgery
Cardiovascular surgery about congenital heart defects with cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Cardiovascular surgery with cardiopulmonary bypass | |
| Group 2 | without family anamnesis confounding factors Receives: Procedure: Cardiovascular surgery with cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Mar 2019
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Kemerovo State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evgeny Grigoryev, Kemerovo State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565299
- Sponsor's protocol ID
- 6
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Speech Disorders in 5-7 Years Old Children With Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT06565299
- Acronym / sponsor ID
- 6
- Conditions
- Cognition Disorder
- Keywords
- cognitive disoders, heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Kemerovo State Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Cardiovascular surgery with cardiopulmonary bypassChildren 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). |
| Group 2 | – | Procedure: Cardiovascular surgery with cardiopulmonary bypasswithout family anamnesis confounding factors |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 5-7 years old children with congenital heart defects bofore abd after cardiovascular operation with cardiopulmonary bypass
Key inclusion criteria (1 listed)
- children with congenital heart disease that required total correction using cardiopulmonary bypass
Key exclusion criteria (1 listed)
- patients with heart disease requiring palliative or endovascular correction, as well as children with chromosomal and genetic diseases (determined by karyotyping)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular surgery with cardiopulmonary bypassCardiovascular surgery about congenital heart defects with cardiopulmonary bypass | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition Disorder, run by Kemerovo State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive status (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.