Impact of intensified nutritional Intervention on Weight Gain in infants with unoperated congenital heart disease in age group between 0-6 months: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mean Z score of weight for height of case and control at the end of study period will be compared.
研究概览
简要总结
Infants with congenital heart disease (CHD) are prone to have poor nutritional status which results in poor growth, recurrent infections and increased postoperative complication. There are consensus guidelines for optimizing nutritional status but there is lack of evidence. Through this study we aim to assess whether Intensified nutritional intervention improves weight gain in infants age group between 0-6 months with unoperated CHD. All infants less than 4 months of age with high nutritional risk cardiac lesion presenting to division of pediatric cardiology OPD with unoperated CHD will be enrolled and randomized into 2 groups - control and intervention group. Baseline anthropometry data will be recorded.
For Control group - The mother will be counselled to give at least 8-12 feeds per 24 hours, and ad lib breastfeeding will be given. For patient on top feed, volume of feed given is at least 120ml/kg/day by KS and ad lib. Patient with weight for height below -3SD will be advised to give at least 100 Kcal/Kg/day.
Intervention group – additional calories will be provided depending on the current nutritional state of the patient as described below. Additional calories will be provided by adding sugar and medium chain triglyceride (MCT) oil to the milk-based diet. If an infant is on breast feeding it will be continued.
- Dietary plan A – given to infants with weight for height above -2 standard deviation on WHO growth standards. Total volume of feed required in the intervention group will be calculated with a target of 100kcal/kg/day. Mothers will be counselled to provided 50-80 percent of total feed by EBM with Katori-spoon feeding, breastfeeding will be continued.
- Dietary plan B – given to infants with weight for height between -2 to -3 standard deviation on WHO growth standards. Total calorie provided will be 110-120 Kcal/kg/day in additional to breastfeed.
- Dietary plan C – given to infants with weight for height below -3 standard deviation on WHO growth standards. Total calorie provided will be 130-150 Kcal/kg/day in additional to breastfeed.
Patient will be followed every 14 days for a period of 2 months after enrollment. Mean Z score of weight for height of case and control at the end of study period will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 4.00 Month(s)（—）
- 性别
- All
入选标准
- •All infants less than 4 months of age with high nutritional risk cardiac lesion presenting to division of pediatric cardiology OPD with unoperated congenital heart disease.
排除标准
- •Failure to obtain consent
- •Non cardiac chronic conditions impacting growth eg.
- •Inborn errors of metabolism, severe Liver/Renal dysfunction
- •Prematurity (less than 37 wks)
- •Chronic diseases (cystic fibrosis, tuberculosis, HIV, Infective endocarditis)
- •Malabsorption
- •Syndromic infants
- •Patient already on milk fortified with sugar and MCT oil.
结局指标
主要结局
Mean Z score of weight for height of case and control at the end of study period will be compared.
时间窗: baseline, 2nd week, 4th week and 6th week, 8th week
次要结局
- Weight Gain Velocity between two groups(2 months)
- To assess the frequency of lower respiratory tract infections and hospital admissions in control and(intervention group.)