Role of Metabolic Evaluation in Infants presenting with Global Developmental Delay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To establish the role of initial metabolic workup, Tandem Mass Spectrometry (TMS) and Gas Chromatography- Mass Spectrometry (GC-MS) in infants presenting with global developmental delay.
研究概览
简要总结
This study is a prospective, clinical: single centre, observational study to determine the role of metabolic workup in children aged 3 months to 2 years with Global Developmental Delay (GDD) and to study the clinical profile of children aged 3 months to 2 years presenting with GDD requiring metabolic workup. This study will be conducted in a single centre in India- Department of Paediatrics, Kasturba Medical College and Hospital, MAHE, Manipal, Karnataka, India. The primary outcome is to establish the role of metabolic workup in children aged 3 months to 2 years presenting with GDD. The secondary outcome is to obtain the clinical profile of children aged 3 months to 2 years presenting with GDD requiring metabolic workup.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 1.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 1 month to 1 year admitted in the Department of Paediatrics and presenting with GDD (global developmental delay with unclear etiology, progressive encephalopathy with seizures, hypotonia with or without poor feeding, failure to thrive, respiratory distress or vomiting).
- •Children with hypoglycaemic encephalopathy.
排除标准
- •Children lesser than 1 month of age or older than 1 year at presentation.
- •Children with identified causes of GDD such as perinatal asphyxia/ hypoxic ischaemic encephalopathy stage 2 or 3, TORCH infections, post-meningitis sequelae, chromosomal disorder, hypothyroidism etc.
结局指标
主要结局
To establish the role of initial metabolic workup, Tandem Mass Spectrometry (TMS) and Gas Chromatography- Mass Spectrometry (GC-MS) in infants presenting with global developmental delay.
时间窗: 2 years
次要结局
- To obtain the clinical profile of infants presenting with GDD requiring metabolic workup.