The Efficacy of High Density Formula 1.5 kcal/ml or 1 kcal/ml On Catch Up Growth In Growth Faltering Children

Completed

• Conditions: High Density Formula; Catch Up Growth; Growth Faltering

• Registration Number: NCT06160765
• Lead Sponsor: Universitas Airlangga

Brief Summary

High density calorie is an Oral Nutrition Supplement (ONS) which is a high calorie formula (High Density Formula) and suggested as nutritional therapy to assist children who are undernourished or undergoing growth faltering. The World Health Organization (WHO) and the Indonesian Ministry of Health have established regulations governing the use of ONS for children suffering from undernutrition, whether or not an infection is present. ONS available on the Indonesian market provides an energy density of between 1-1.5 kcal/ml.

This study has the potential to clarify the advantages of ONS administration and evaluate its efficacy in comparison to nutritional therapy (1 kcal/ml or 1.5 kcal/ml) to facilitate rapid catch-up growth by examining the rate of increase in body weight, body lenght and undernourished children, particularly when infection is present.

Purposes:

1. Analyze the effect of the 1.5 kcal/ml high dense formula (ONS) on the average weight gain in undernourished children accompanied by infections

2. Analyze the effect of the 1.5 kcal/ml calorie dense formula (ONS) on the average increase in PB in undernourished children accompanied by infections

3. Analyze the effect of the 1 kcal/ml calorie dense formula (ONS) on the average weight gain in undernourished children accompanied by infections

4. Analyze the effect of 1 kcal/ml calorie dense formula (ONS) on the average increase in PB in undernourished children accompanied by infections

5. Analyze the effect of the 1.5 kcal/ml calorie dense formula (ONS) on changes in nutritional status in undernourished children accompanied by infections

Detailed Description

This research is a retrospective observational study using medical record data from the EMR Husada Utama Hospital. Based on the EMR, data will be taken on patients who are able to consume 300-400 kcal of solid food, given 400 cc ONS 1.5 kkal/ml (Nutrini drink) equivalent to 600 kcal as group 1. Patients who are able to consume 500-600 kcal solid food are given 1 kkal/ml 400 cc ONS (SGM optigrow) equivalent 400 kcal as group 2. The rate of increase body weight and body height will be measured at day 0, 30 , 60 and 90 after consumed high dense formula, then it will be plotted in WHO Growth Chart to show the enhancement of nutrition status.

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.

Study Timeline

• Study Start: 2023-11-27
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study First Posted: 2023-12-07
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Children aged 1 years - 5 years, are diagnosed tuberculosis (TB) and urinary tract infection (UTI)
• Children who have feeding difficulties
• Children who malnourished or have undergoing weight malnutrition

Exclusion Criteria

• Children with fluid retention
• Children with organomegaly
• Children with tumor masses.
• Children with congenital abnormalities
• Children wither cerebral palsy, hormonal disorders, and syndromes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body Height	3 months	Body height will be measured using Seca 213 stadiometer. The subjects were asked to step at the stadiometer base in an upright state, with the heel, the buttock, and the shoulder blade touching the scale pool. The chin up, look straight ahead. The head slider was lowered until it touches the cranium. Noted the body height in the data collection sheet (presenting in mean +/- SD, in cm). The subject must use light clothes without accessories or footwear, such as hats or hair ponytail.
Body Weight	3 months	Body weight will be measured using Tanita RD 953-BK digital scale (presenting in mean +/- SD, in kg). The subjects were asked to step at the scale in an upright state. The body weight appears on the screen and is then noted in the data collection sheet. The subject must use light clothes without accessories or footwear

Trial Locations

Locations (1)

Husada Utama Hospital; 🇮🇩 Surabaya, East Java, Indonesia