Assessment of somatic growth and nutritional status of infants 0-3 months of age undergoing enterostomy: a prospective study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- of the following parameters
研究概览
简要总结
This study aims to assess the somatic growth and nutritional status of neonates and infants less than 3 months of age with who underwent enterostomy .
The primary aim - To assess somatic growth in neonates undergoing enterostomy by means of the following parameters 1. Weight 2. Length 3. Head circumference
The secondary aim - To assess: 1. Micronutrient deficiencies 2. Electrolyte disturbances 3. Correlation of growth failure with length of proximal gut 4. Incidence of hypoproteinemia
This is a prospective study and will be conducted in Department of Pediatric Surgery, PGIMER from May 2023 to December 2024 Details of the study Study location: Department of Pediatric Surgery, PGIMER, Chandigarh Study population: Patients less the 3 months of age undergoing abdominal enterostomy (/jejunostomy/ileostomy/ colostomy). These will be divided into 2 groups – ileostomy/jejunostomy group and colostomy group Sample size: A sample size of 150 patients will be taken. Each patient will be allocated to one of these 2 groups – ileostomy/jejunostomy or colostomy. 50 patients will be taken in each group. Same number of controls will be taken from the infants less than 3 months coming to OPD/ward for issues unrelated to gastrointestinal tract.
Method of collection of data: A detailed proforma will be filled up for each of the assessment parameters • At discharge • At 1 month follow up • At 3 month follow up • At 6 month follow up (earlier if stoma closure planned early)
Anthropometric parameters: • Weight for age • Length for age • Weight for Length • Head circumference for age
Parameters to be seen at discharge and at 6 month follow up (earlier if stoma closure planned early): 1. Serum calcium 2. Serum phosphorus 3. Serum alkaline phosphate 4. Hemoglobin and iron studies 5. Serum magnesium 6. Total protein/ albumin 7. TFT(T3/T4/TSH) Parameters to be seen at 6 month follow up (earlier if stoma closure planned early): 1. Micronutrients - copper and zinc 2. Serum triglyceride levels 3. Serum vitamin b12 4. Serum vitamin D 5. Serum folate Parameters to be seen at discharge, at 1 month follow up, at 3 month followup, 6 month follow up (earlier if stoma closure planned early) 1. Serum and urinary sodium 2. Serum potassium
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Month(s)（—）
- 性别
- All
入选标准
- •Neonates undergoing excretory enterostomy.
- •Infants less than 3 months undergoing excretory enterostomy.
排除标准
- •Children with complex cardiac disorders.
- •Children with Suspected syndromes or Aneuploidy Children in whom parental consent is not available.
结局指标
主要结局
of the following parameters
时间窗: at diacharge, 1 month, 3 month, 6 month follow up
To assess somatic growth in neonates undergoing enterostomy by means
时间窗: at diacharge, 1 month, 3 month, 6 month follow up
Weight,Length,Head circumference
时间窗: at diacharge, 1 month, 3 month, 6 month follow up
次要结局
- To assess:(1. Micronutrient deficiencies)
研究者
Kaashvi Udwani
Post Graduate institute of medical education and research(PGIMER), Chandigarh