Neurodevelopment in Congenital Heart Disease Children at One Year Using Global Scales of Early Development Compared to Age Matched Control-An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Global Scales for Early Development (GSED)
研究概览
简要总结
This observational study aims to evaluate the neurodevelopment of one-year-old children with congenital heart disease (CHD) using the Global Scales of Early Development (GSED), comparing their outcomes with age-matched healthy controls. CHD is one of the most common congenital disorders globally and in India, with significant survival improvements due to advancements in medical and surgical care. However, children with CHD remain at high risk for neurodevelopmental delays due to factors such as chronic hypoxia, altered cerebral blood flow, perioperative complications, and prolonged hospitalization. The study highlights the importance of early assessment during infancy, a critical period for brain development, to identify potential delays in cognitive, motor, language, and socio-emotional skills.
he research will be conducted in a tertiary care hospital and Anganwadi centers, enrolling 70 children aged 12 to 15 months—35 diagnosed with CHD and 35 healthy controls. Using both the caregiver-reported short form and the professionally administered long form of the GSED, the study will generate developmental scores (D-scores) to assess and compare neurodevelopment across multiple domains. The selection will follow specific inclusion and exclusion criteria, and data will be collected through informed consent, demographic recording, and standardized developmental assessments.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Month(s) 至 15.00 Month(s)(—)
- 性别
- All
入选标准
- •Children age 12-15 month diagnosed with congenital heart disease Healthy children between 12-15 month for control group.
排除标准
- •Preterm birth Genetic conditions Neurological disorder syndrome conditions.
结局指标
主要结局
Global Scales for Early Development (GSED)
时间窗: BASELINE TO, AT THE START OF THE STUDY ONLY
次要结局
未报告次要终点
研究者
Dr Deepa Metgud
KAHER Institute of physiotherapy, Belgavi 510010
