Growth Faltering Clinical Trial
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
Verified date | May 2024 |
Source | Universitas Airlangga |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | June 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 5 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Husada Utama Hospital | Surabaya | East Java |
Lead Sponsor | Collaborator |
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Universitas Airlangga |
Indonesia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Maleta K. Undernutrition. Malawi Med J. 2006 Dec;18(4):189-205. No abstract available. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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 | |
Primary | 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 |
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