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临床试验/CTRI/2025/08/093311
CTRI/2025/08/093311已完成不适用

Neurodevelopment in Congenital Heart Disease Children at One Year Using Global Scales of Early Development Compared to Age Matched Control-An Observational Study

KAHER Institute of Physiotherapy1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月1日最近更新:

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

发起方
KAHER Institute of Physiotherapy
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Deepa Metgud

KAHER Institute of physiotherapy, Belgavi 510010

研究点 (1)

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