Growth FalteringNCT06160765
The Efficacy of High Density Formula 1.5 kcal/ml or 1 kcal/ml On Catch Up Growth In Growth Faltering Children
An observational study of Growth Faltering and High Density Formula, run by Universitas Airlangga at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Growth Faltering, High Density Formula, Catch Up Growth
- How many people
- 150 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Nov 2023to 30 Jun 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Children with fluid retention
- Children with organomegaly
- Children with tumor masses.
- Children with congenital abnormalities
- Children wither cerebral palsy, hormonal disorders, and syndromes.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
Purposes:
- Analyze the effect of the 1.5 kcal/ml high dense formula (ONS) on the average weight gain in undernourished children accompanied by infections
- 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
- Analyze the effect of the 1 kcal/ml calorie dense formula (ONS) on the average weight gain in undernourished children accompanied by infections
- Analyze the effect of 1 kcal/ml calorie dense formula (ONS) on the average increase in PB in undernourished children accompanied by infections
- Analyze the effect of the 1.5 kcal/ml calorie dense formula (ONS) on changes in nutritional status in undernourished children accompanied by infections
Read the 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.
- Conditions
- Growth Faltering, High Density Formula, Catch Up Growth
- Keywords
- Growth Failure, Growth Faltering, High Density Formula, Catch Up Growth
- Medical subject headings
- Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start27 Nov 2023
- Primary completion30 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Growth FalteringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Aisiyah Widjaja, Universitas Airlangga
- Investigators
- Nur Aisiyah Widjaja, Ph.D, Principal investigator, Child Health Department, Faculty of Medicine, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160765
- Sponsor's protocol ID
- High Density Formula
- Other IDs
- UA number
- Status last verified
- Jul 2024
- First submitted
- 29 Nov 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maleta K. Undernutrition. Malawi Med J. 2006 Dec;18(4):189-205. No abstract available.
PubMed 27529011Zhang 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.
PubMed 34578914Thomson 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.
PubMed 36116457Pedrianes-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.
PubMed 36904218Devaera 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.
PubMed 30345245Stratton 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.
PubMed 20696091Ui 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.
PubMed 29521557Hubbard 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.
PubMed 32170451Loman 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.
PubMed 30565718Adu-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.
PubMed 17684213
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06160765
- Acronym / sponsor ID
- High Density Formula
- Conditions
- Growth Faltering, High Density Formula, Catch Up Growth
- Keywords
- Growth Failure, Growth Faltering, High Density Formula, Catch Up Growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Analyze the effect of the 1.5 kcal/ml high dense formula (ONS) on the average weight gain in undernourished children accompanied by infections
- 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
- Analyze the effect of the 1 kcal/ml calorie dense formula (ONS) on the average weight gain in undernourished children accompanied by infections
- Analyze the effect of 1 kcal/ml calorie dense formula (ONS) on the average increase in PB in undernourished children accompanied by infections
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Children with fluid retention
- Children with organomegaly
- Children with tumor masses.
- Children with congenital abnormalities
- Children wither cerebral palsy, hormonal disorders, and syndromes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 27529011Maleta K. Undernutrition. Malawi Med J. 2006 Dec;18(4):189-205. No abstract available.
- Background: PubMed 34578914Zhang 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.
- Background: PubMed 36116457Thomson 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.
- Background: PubMed 36904218Pedrianes-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.
- Background: PubMed 30345245Devaera 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.
- Background: PubMed 20696091Stratton 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.
- Background: PubMed 29521557Ui 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.
- Background: PubMed 32170451Hubbard 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.
- Background: PubMed 30565718Loman 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.
- Background: PubMed 17684213Adu-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.
- Individual participant dataSharing planned: No
Related trials for Growth Faltering
Not yet recruiting
Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
Faltering Growth, Failure to Thrive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Aisiyah Widjaja, Ph.D principal investigator
Child Health Department, Faculty of Medicine, Universitas Airlangga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Faltering and High Density Formula, run by Universitas Airlangga at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06160765, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.