Cognitive and Speech Disorders in 5-7 Years Old Children With Congenital Heart Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- Neurocognitive status
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with congenital heart disease that required total correction using cardiopulmonary bypass
排除标准
- •patients with heart disease requiring palliative or endovascular correction, as well as children with chromosomal and genetic diseases (determined by karyotyping)
研究组 & 干预措施
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).
干预措施: Cardiovascular surgery with cardiopulmonary bypass (Procedure)
Group 2
without family anamnesis confounding factors
干预措施: Cardiovascular surgery with cardiopulmonary bypass (Procedure)
结局指标
主要结局
Neurocognitive status
时间窗: 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.
次要结局
未报告次要终点
研究者
Evgeny Grigoryev
Head of the Department of Anesthesiology
Kemerovo State Medical University