Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to Ready-to-Drink High Energy and Standard Energy Oral Nutrition Supplement Compared to Formula-75/Formula-100
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Gastrointestinal tolerance for vomit
研究概览
简要总结
The primary outcome of the study is to identify gastrointestinal tolerance of under-five children with severe acute malnutrition to ready-to-drink high energy (1.5 kcal/ml) and standard energy (1 kcal/ml) oral nutrition supplement (ONS) compared to Formula-75/Formula-100. The secondary outcomes of the study are weight gain, electrolyte profile and plasma amino acid profile at the beginning and the end of stabilization phase.
In this randomized, controlled trial, 108 patients with severe acute malnutrition will be enrolled. Patients are randomly assigned to 3 groups (Formula-75/Formula-100, high energy ONS, and standard energy ONS) to undergo a two-week treatment. In order to ensure an adequate intake, nasogastric-tube will be placed for home enteral nutrition for at least throughout the two-week study period. Parent or caregiver will be asked to record daily intake, vomit, and defecation score using Bristol stool chart.
详细描述
The study compares 3 groups of nutrition intervention for severe acute malnourished children aged 6-59 months in terms of gastrointestinal tolerance (primary outcome) and weight gain, electrolyte profile, and amino acid profile (secondary outcomes).
The gastrointestinal tolerance is examined by Bristol stool chart and vomit daily record during 14 days of intervention. Diarrhea is defined according to ESPGHAN, i.e. a decrease in the consistency of stools score (loose or liquid) and an increase in the frequency of evacuations (typically 3 or more in 24 hours). The duration of diarrhea, frequency of diarrhea, and consistency of each stool are recorded.
Vomit will be counted as mean frequency of vomit per day during 14 days intervention. Volume of vomit is recorded. Only vomit due to milk intolerance is counted. Vomit due to irrelevant reasons, such as coughing and crying, will be excluded.
To ensure accurate formula intake, nasogastric tube is placed and patient is admitted for observation for a few days, depending on clinical conditions. Patient is discharged to undergo home enteral nutrition after parent is trained to administer formula and to clean all feeding devices properly. Parents of group F-75/F-100 is trained to make F-75/F-100 at home with hygienic procedure.
The volume of milk intake is recorded daily. Patient is advised not to eat food/drink milk other than the intervention formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 12-60 months
- •Weight for length/height z score < -3 (WHO 2006)
- •Not on nutritional treatment of severe acute malnutrition for the last 1 month
排除标准
- •Not willing to take part in this study
- •Having diarrhea
- •Diagnosed with malignancy or suspected malignancy
结局指标
主要结局
Gastrointestinal tolerance for vomit
时间窗: 14 days
Frequency of vomit per day and volume of vomit
Gastrointestinal tolerance for bowel movement
时间窗: 14 days
Frequency of bowel movement per day and description of stool consistency (Bristol stool chart)
次要结局
- Changes of plasma amino acid concentration(Day 1 and day 14)
- Weight gain(14 days)
- Height gain(14 days)
- Prevalence of hypophosphatemia(Day 1 and day 3)
- Prevalence of hypokalemia(Day 1 and day 3)
- Prevalence of hypomagnesemia(Day 1 and day 3)
研究者
Klara Yuliarti
Principal Investigator
Indonesia University