High Calorie Formula Intervention on Weight, Length, Total Lymphocyte Count, TNF-α and IGF-1 in Growth Faltering Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The effectiveness of high calorie formula on the subjects
研究概览
简要总结
High calorie formula (Oral Nutrition Supplement/ONS) are products used for oral nutrition support with the aim to increase the nutritional intake. they are a nutrition treatment option children with limited intake. ONS are typically used in addition to a normal diet, when diet alone is insufficient to meet daily nutritional requirement due to infection or others. ONS should be treated like medication, ensure they are labelled with the patient's name and provided at the prescribed time.
It is well established that nutritional deficiency or inadequate can impair immune function. Growing evidence suggest that for certain conditions, the nutrient needs will be increased, so it is needed to provide the nutrient intake above currently recommended levels, in order to help optimizing the immune function, including improving the defense function and thus resistance to infection while maintaining tolerance.
Purposes:
- to analyze the effect of high calorie formula on IGF-1 levels in children with failure to thrive
- to analyze the effect of high calorie formula on total lymphocyte counts with failure to thrive
- to analyze the effect of high calorie formula on TNF-alpha levels in children with failure to thrive
Hypothesis:
- there is significant increment of IGF-1 levels before and after the intervention
- there is significant difference of total lymphocyte counts before and after the intervention
- there is significant difference of TNF-alpha levels before and after the intervention
详细描述
Interventional study with pre-, post-test design. After the subject were diagnosed with infection (tuberculosis/TB or urinary tract infection/ UTI, the diagnosed will be determined by a pediatrician/the researcher based on clinical examination and laboratory findings), they will receive 400 kcal/day (96 g/day divided 4 times consumption) of high calorie formula prescribed by the researcher (A pediatrician) for 90 days consumption (8640 g). the subject will monitored every 30 days for acceptance, tolerance, weight increment, length increment evaluation until the end of study (90 day intervention).
The blood will be withdrawn at day 0 (before invention) and day 90 (after intervention) to measure the levels of TNF-alpha, IGF-1 and total lymphocyte count. Total lymphocyte count (TLC) was measured based on the complete blood report (white blood cells x 1000 x % lymphocyte). The high calorie formula is given as much as 400 kcal/day for 90 days after the subject were diagnosed with tuberculosis (TB) or urinary tract infection (UTI), determine as day 1. Before the intervention (day 0) and after the intervention (day 90), the subjects were taken the blood by laboratory employee of the private hospital in Surabaya, Indonesia.
The statistical analysis including test of normality and homogeneity test, followed by paired sample T-test or Wilcoxon, depend on the normality and homogeneity test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 years - 5 years, are diagnosed tuberculosis (TB) and urinary tract infection (UTI)
排除标准
- •Congenital Disease
- •Congenital Heart Disease
- •Organomegaly
- •Cerebral palsy and genetic syndromes
- •Hormonal abnormality/disorders
- •Drop out criteria:
- •Lost contact
结局指标
主要结局
The effectiveness of high calorie formula on the subjects
时间窗: 90 days
Change on body weight. The data will be presented as mean +/- SD (standard deviation). The body weight will be measure with baby Scale Seca 354 (in grams) for subjects \<24 months age, and using Seca electronic flat scale 813 (in grams) for subjects \>24 months age
次要结局
- The effectiveness of high calorie formula on the subjects(90 days)
研究者
Andy Darma, MD
Principal Investigator on Gastroenterology
Universitas Airlangga