Clinical trial NCT06160765: The Efficacy of High Density Formula 1.5 kcal/ml or 1 kcal/ml On Catch Up Growth In Growth Faltering Children
Official title: The Efficacy of High Density Formula1.5 kcal/ml or 1 kcal/ml On Catch Up Growth In Growth Faltering Children With Feeding Difficulties
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Faltering
High Density Formula
Catch Up Growth
Keywords: Growth Failure
Growth Faltering
High Density Formula
Catch Up Growth
Lead sponsor: Universitas Airlangga
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study collect EMRs of private patients at the outpatient pediatric clinic at the Husada Utama Hospital, with a range of November 2021-November 2023 who met the inclusion and exclusion criteria to reach the desired population

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Weight
timeFrame: 3 months
measure: Body Height
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Husada Utama Hospital
state: East Java
Study officials:
affiliation: Child Health Department, Faculty of Medicine, Universitas Airlangga
name: Nur Aisiyah Widjaja, Ph.D
role: PRINCIPAL_INVESTIGATOR
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