An interventional study of high calorie formula (oral nutritional supplement/ONS) in Failure to Thrive, Infection, Bacterial and Growth Faltering, sponsored by Universitas Airlangga. Completed at 1 site in Indonesia. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Universitas Airlangga · Not applicable, Interventional, and Supportive care
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:
Hypothesis:
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The blood will be withdrawn at day 0 (before invention) and day 90 (after intervention) to measure the levels of TNF-alpha, IGF-1 and total lymphocyte count.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.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's enrollment of 80 is below the median of 100 across 56 interventional studies indexed under Failure to Thrive.
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Exclusion Criteria:
Drop out criteria:
Interventional study with pre-, post design after the subjects are diagnosed with TB and UTI, they will receive 400 ml (equal with 400 kcal) of high calorie formula per day, prescribed by the researcher (a pediatrician) for 90 days consumption. Body weight and body height will be monitored by the researcher group every 30 days to record the tolerance, acceptance and complaints (and the side effects) the blood will be withdraw at day 0 (before intervention) and day 90 (after intervention) to investigate the IGF-1, TNF-alpha and total lymphocyte counts
Dietary Supplement: high calorie formula (oral nutritional supplement/ONS)
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.
Also known as: formula for special medical purposes
The effectiveness of high calorie formula on the subjects
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
Time frame: 90 days
The effectiveness of high calorie formula on the subjects
Change on body height/length. The data will be presented as mean +/- SD (standard deviation). The body height/length will be measure with infantometer Seca 416 (in cm) for subject \<24 months age, and using stadiometer Seca 213 (in cm) for subjects \>24 months age
Time frame: 90 days
The effectiveness of high calorie formula on the subjects
Change on IGF-1 levels (in ng/ml) will be presented as mean +/- SD (standard deviation). IGF-1 levels will be measured using Human IGF-1 Elisa kit 96 T (BT LAB),
Time frame: day 0 pre intervention, day 91 post intervention
The effectiveness of high calorie formula on the subjects
The change on total lymphocyte count (TLC) before and after intervention, the data will be presented as mean +/- SD (standard deviation). TLC will measure based on complete blood count (CBC), with formula WBC x 1000 x % lymhocyte, express as a decimal.
Time frame: 90 days
The effectiveness of high calorie formula on the subjects
Change on TNF-alpha levels (in ng/ml) will be presented as as mean +/- SD (standard deviation). TNF-alpha will measure using Human TNF-alpha Elisa kit 96 T (BT LAB).
Time frame: 90 days
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Universitas Airlangga