The Efficacy of High Density Formula 1.5 kcal/ml or 1 kcal/ml On Catch Up Growth In Growth Faltering Children
NCT ID: NCT06160765
Last Updated: 2024-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2023-11-27
2024-06-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Children who have feeding difficulties
* Children who malnourished or have undergoing weight malnutrition
Exclusion Criteria
* Children with organomegaly
* Children with tumor masses.
* Children with congenital abnormalities
* Children wither cerebral palsy, hormonal disorders, and syndromes.
1 Year
5 Years
ALL
No
Sponsors
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Universitas Airlangga
OTHER
Responsible Party
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Nur Aisiyah Widjaja
Principal Investigator on Nutrition and Metabolic Disease
Principal Investigators
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Nur Aisiyah Widjaja, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Child Health Department, Faculty of Medicine, Universitas Airlangga
Locations
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Husada Utama Hospital
Surabaya, East Java, Indonesia
Countries
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References
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Maleta K. Undernutrition. Malawi Med J. 2006 Dec;18(4):189-205. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UA number
Identifier Type: OTHER
Identifier Source: secondary_id
High Density Formula
Identifier Type: -
Identifier Source: org_study_id
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