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

July 19, 2024 updated by: Nur Aisiyah Widjaja, Universitas Airlangga

The Efficacy of High Density Formula1.5 kcal/ml or 1 kcal/ml On Catch Up Growth In Growth Faltering Children With Feeding Difficulties

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60131
        • Husada Utama Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1.5 kcal/ml High Density Formula
This group consist of patients who are able to consume 300-400 kcal of solid food and given 400 cc High Density Formula 1.5 kcal/ml equivalent to 600 kcal
1 kcal/ml High Density Formula
This group consist of patients who are able to consume 500-600 kkal of solid food and given 400 cc High Density Formula 1 kcal/ml equivalent to 400 kcal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: 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
3 months
Body Height
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Airlangga

Investigators

  • Principal Investigator: Nur Aisiyah Widjaja, Ph.D, Child Health Department, Faculty of Medicine, Universitas Airlangga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • High Density Formula
  • UA number (Other Identifier: Airlangga University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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