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

NCT06160765 | Completed

• 2 other identifiers: High Density FormulaUA number
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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. 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

Conditions

Growth Faltering; High Density Formula; Catch Up Growth

Keywords

Growth Failure; Growth Faltering; High Density Formula; Catch Up Growth

Outcome Measures

Primary Outcomes (2)

• Body Weight

  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

  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

Study Arms (2)

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

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Airlangga: lead

Study Sites (1)

Husada Utama Hospital

Surabaya, East Java, 60131, Indonesia

Location

Related Publications (10)

• Maleta K. Undernutrition. Malawi Med J. 2006 Dec;18(4):189-205. No abstract available.

  PMID: 27529011 BACKGROUND

• Zhang Z, Li F, Hannon BA, Hustead DS, Aw MM, Liu Z, Chuah KA, Low YL, Huynh DTT. Effect of Oral Nutritional Supplementation on Growth in Children with Undernutrition: A Systematic Review and Meta-Analysis. Nutrients. 2021 Aug 30;13(9):3036. doi: 10.3390/nu13093036.

  PMID: 34578914 BACKGROUND

• Thomson KH, Rice S, Arisa O, Johnson E, Tanner L, Marshall C, Sotire T, Richmond C, O'Keefe H, Mohammed W, Raffle A, Hanratty B, McEvoy CT, Craig D, Ramsay SE. Effectiveness and cost-effectiveness of oral nutritional supplements in frail older people who are malnourished or at risk of malnutrition: a systematic review and meta-analysis. Lancet Healthy Longev. 2022 Oct;3(10):e654-e666. doi: 10.1016/S2666-7568(22)00171-4. Epub 2022 Sep 15.

  PMID: 36116457 BACKGROUND

• Pedrianes-Martin PB, Dassen-de-Monzo C, Guardia-Baena JM, Riestra-Fernandez M, Salom-Vendrell C, PerceptiONS Group, Calvo-Barbero A, Lizan-Tudela L. Physicians' Perception of Oral Nutritional Supplement Acceptance and Tolerability in Malnourished Outpatients: PerceptiONS Study. Nutrients. 2023 Feb 28;15(5):1219. doi: 10.3390/nu15051219.

  PMID: 36904218 BACKGROUND

• Devaera Y, Syaharutsa DM, Jatmiko HK, Sjarif DR. Comparing Compliance and Efficacy of Isocaloric Oral Nutritional Supplementation Using 1.5 kcal/mL or 1 kcal/mL Sip Feeds in Mildly to Moderately Malnourished Indonesian Children: A Randomized Controlled Trial. Pediatr Gastroenterol Hepatol Nutr. 2018 Oct;21(4):315-320. doi: 10.5223/pghn.2018.21.4.315. Epub 2018 Oct 10.

  PMID: 30345245 BACKGROUND

• Stratton RJ, Elia M. Encouraging appropriate, evidence-based use of oral nutritional supplements. Proc Nutr Soc. 2010 Nov;69(4):477-87. doi: 10.1017/S0029665110001977. Epub 2010 Aug 10.

  PMID: 20696091 BACKGROUND

• Ui Dhuibhir P, Collura N, Walsh D. Complete Oral Nutritional Supplements: Dietitian Preferences and Clinical Practice. J Diet Suppl. 2019;16(1):40-50. doi: 10.1080/19390211.2018.1428260. Epub 2018 Mar 9.

  PMID: 29521557 BACKGROUND

• Hubbard GP, Fry C, Sorensen K, Casewell C, Collins L, Cunjamalay A, Simpson M, Wall A, Van Wyk E, Ward M, Hallowes S, Duggan H, Robison J, Gane H, Pope L, Clark J, Stratton RJ. Energy-dense, low-volume paediatric oral nutritional supplements improve total nutrient intake and increase growth in paediatric patients requiring nutritional support: results of a randomised controlled pilot trial. Eur J Pediatr. 2020 Sep;179(9):1421-1430. doi: 10.1007/s00431-020-03620-9. Epub 2020 Mar 13.

  PMID: 32170451 BACKGROUND

• Loman BR, Luo M, Baggs GE, Mitchell DC, Nelson JL, Ziegler TR, Deutz NE, Matarese LE; NOURISH Study Group. Specialized High-Protein Oral Nutrition Supplement Improves Home Nutrient Intake of Malnourished Older Adults Without Decreasing Usual Food Intake. JPEN J Parenter Enteral Nutr. 2019 Aug;43(6):794-802. doi: 10.1002/jpen.1467. Epub 2018 Nov 22.

  PMID: 30565718 BACKGROUND

• Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Randomized comparison of 3 types of micronutrient supplements for home fortification of complementary foods in Ghana: effects on growth and motor development. Am J Clin Nutr. 2007 Aug;86(2):412-20. doi: 10.1093/ajcn/86.2.412.

  PMID: 17684213 BACKGROUND

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nur Aisiyah Widjaja, Ph.D

  Child Health Department, Faculty of Medicine, Universitas Airlangga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator on Nutrition and Metabolic Disease

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: November 27, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)