High Calorie Formula Intervention on Weight, Length Increment, Total Lymphocyte Counts, TNF-alpha and IGF-1 in Failure to Thrive Children
Condition: Failure to Thrive; Infection, Bacterial; Growth Faltering
MeSH terms: Bacterial Infections; Failure to Thrive
Study type: Interventional

Summary: 
      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:

        1. to analyze the effect of high calorie formula on IGF-1 levels in children with failure
           to thrive

        2. to analyze the effect of high calorie formula on total lymphocyte counts with failure to
           thrive

        3. to analyze the effect of high calorie formula on TNF-alpha levels in children with
           failure to thrive

      Hypothesis:

        1. there is significant increment of IGF-1 levels before and after the intervention

        2. there is significant difference of total lymphocyte counts before and after the
           intervention

        3. there is significant difference of TNF-alpha levels before and after the intervention
    

Detailed description: 
      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.
    

Intervention name(s): high calorie formula (oral nutritional supplement/ONS)
Intervention type(s): Dietary Supplement
Intervention description(s): every subject is given 400 ml (equal with 400 kcal) high calorie formula for 90 days. before (day 0) and after (day 91) the intervention was enrolled, blood samples was taken to investigate IGF-1 and total lymphocyte counts.
The body weight and body height will be measured at day-0, day-14, day-30, day 60 and 90.
Other intervention name(s): formula for special medical purposes
Intervention model: Single Group Assignment
Intervention model description: Pre-, post- intervention study design
Masking: None (Open Label)
Primary purpose: Supportive Care