Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Protocol for formula advancement is as follows:

        -  Calorie requirement is calculated by multiplying ideal weight with daily energy
           requirement (recommended daily allowance, RDA).

        -  Ideal weight is the median weight for actual height based on WHO growth chart (weight
           for height/length).

        -  Height age is the median age corresponding to actual height of patient, based on WHO
           growth chart (height/length for age)

        -  The value of RDA is based on height age, which is 110 kcal/day for height age 0-12
           months and 100 kcal/kg/day

             1. On the first day: patient is given 50-75% of RDA (recommended daily allowance), the
                daily volume of formula (F75/standard energy ONS/high energy ONS) will be divided
                into 8 feeding sessions (every 3 hours). Complete blood count, electrolyte, and
                amino acid profile will be tested prior to administering formula.

             2. On the second day: patient is given 75-90% of RDA as F75/standard energy ONS/high
                energy ONS.

             3. On the third day: patient is given 100% of RDA as F100/standard energy ONS/high
                energy ONS. Serum electrolyte will be tested before administering formula.

      Should there be any electrolyte imbalance, the electrolyte level will be corrected according
      to the clinical guideline.

      Weight and height will be measured on the first day and day 14. Head circumference will be
      measured on the first day.
    

Intervention name(s): High Energy Oral Nutrition Supplement; Standard Energy Oral Nutrition Supplement; Formula-75/Formula-100
Intervention type(s): Other; Other; Other
Intervention description(s): Oral Nutrition Supplement (ONS) or enteral formula is a formula intended to treat individuals who are unable to meet their nutritional requirements through oral diet alone. European Food Safety Authority described ONS as a formula with caloric density >0.9 kcal/mL. Formula with caloric density of >1.2 kcal/mL is categorized as high energy ONS. This intervention has caloric density of 1.5 kcal/mL.; Oral Nutrition Supplement (ONS) or enteral formula is a formula intended to treat individuals who are unable to meet their nutritional requirements through oral diet alone. European Food Safety Authority described ONS as a formula with caloric density >0.9 kcal/mL. This intervention has caloric density of 1 kcal/mL and it is categorized as standard energy ONS.; Formula-75/Formula-100 is a special therapeutic foods to treat children with severe acute malnutrition. WHO designed F75 as a starter formula for stabilization phase with 75 kcal/100 mL, then it is continued with F100 for rehabilitation phase with 100 kcal/100 mL Formula-75 and Formula-100 are made according to recipe from WHO. The ingredients are skimmed milk powder, coconut oil, and sugar. Mineral mix is added, i.e. 2 ml every 100 ml of formula.
The composition of F-75:
Skimmed milk 25 g, coconut oil 100 g, sugar 30 g, mineral mix 20 ml, add water to 1000 ml
The composition of F-100:
Skimmed milk 80 g, coconut oil 50 g, sugar 60 g, mineral mix 20 ml, add water to 1000 ml
Other intervention name(s): High Energy ONS; Standard Energy ONS; F75/F100
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: severe acute malnutrition; oral nutrition supplement; Formula-75/Formula-100; Under-five children