Clinical trial NCT05333133: High Calorie Formula Intervention on Weight, Length Increment, Total Lymphocyte Counts, TNF-alpha and IGF-1 in Failure to Thrive Children
Official title: High Calorie Formula Intervention on Weight, Length, Total Lymphocyte Count, TNF-α and IGF-1 in Growth Faltering Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failure to Thrive
Infection, Bacterial
Growth Faltering
Lead sponsor: Universitas Airlangga
Sponsor class: OTHER
Collaborators: name: Danone Institute International
First posted: 2022-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-, post- intervention study design
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Children aged 1 years - 5 years, are diagnosed tuberculosis (TB) and urinary tract infection (UTI)

Exclusion Criteria:

* Congenital Disease
* Congenital Heart Disease
* Edema
* Organomegaly
* Tumor
* Cerebral palsy and genetic syndromes
* Hormonal abnormality/disorders

Drop out criteria:

* Lost contact

Primary outcomes:
measure: The effectiveness of high calorie formula on the subjects
timeFrame: 90 days
measure: The effectiveness of high calorie formula on the subjects
timeFrame: 90 days
measure: The effectiveness of high calorie formula on the subjects
timeFrame: day 0 pre intervention, day 91 post intervention
measure: The effectiveness of high calorie formula on the subjects
timeFrame: 90 days
Secondary outcomes:
measure: The effectiveness of high calorie formula on the subjects
timeFrame: 90 days
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Husada Utama Hospital
state: East Java
Study officials:
References: