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High Calorie Formula Intervention on Weight, Length Increment, Total Lymphocyte Counts, TNF-alpha and IGF-1 in Failure to Thrive Children

Primary Purpose

Failure to Thrive, Infection, Bacterial, Growth Faltering

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
high calorie formula (oral nutritional supplement/ONS)
Sponsored by
Universitas Airlangga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Failure to Thrive

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Husada Utama Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High calorie formula on IGF-1, TNF-alpha and total lymphocyte counts

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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),
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.

Secondary Outcome Measures

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).

Full Information

First Posted
March 25, 2022
Last Updated
June 20, 2023
Sponsor
Universitas Airlangga
Collaborators
Danone Institute International
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1. Study Identification

Unique Protocol Identification Number
NCT05333133
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Airlangga
Collaborators
Danone Institute International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure to Thrive, Infection, Bacterial, Growth Faltering

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-, post- intervention study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High calorie formula on IGF-1, TNF-alpha and total lymphocyte counts
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
high calorie formula (oral nutritional supplement/ONS)
Other Intervention Name(s)
formula for special medical purposes
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effectiveness of high calorie formula on the subjects
Description
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
Title
The effectiveness of high calorie formula on the subjects
Description
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
Title
The effectiveness of high calorie formula on the subjects
Description
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
Title
The effectiveness of high calorie formula on the subjects
Description
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
Secondary Outcome Measure Information:
Title
The effectiveness of high calorie formula on the subjects
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Husada Utama Hospital
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60131
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High Calorie Formula Intervention on Weight, Length Increment, Total Lymphocyte Counts, TNF-alpha and IGF-1 in Failure to Thrive Children

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