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This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.
A four week, multi-centre, randomised controlled trial investigating the effects of a high energy density, low volume oral nutritional supplement versus standard energy density oral nutritional supplements in children aged 1-12yrs old requiring nutritional support. Fifty eligible children will be recruited and randomised to receive either the high energy density oral nutritional supplement or the standard energy density oral nutritional supplement for four weeks. The primary outcome is nutrient intake, with secondary outcomes of compliance, tolerance, acceptability, anthropometry and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | The group who will receive high energy density, low volume oral nutritional supplement, to be taken for 4 weeks (28 days) |
|
| Group B | Active Comparator | The group who will receive the standard energy density oral nutritional supplement, to be taken for 4 weeks (28 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HE ONS | Other | High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nutrient intake | Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study. | 4 weeks (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance: Compliance with oral nutritional supplements in Group A and Group B; how much of the oral nutritional supplement is taken in comparison to the amount advised by the Dietitian. | 4 weeks (28 days) | |
| Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32170451 | Derived | 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. |
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| ID | Term |
|---|---|
| D005183 | Failure to Thrive |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| SE ONS | Other | Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management |
|
| 4 weeks (28 days) |
| Acceptability: How acceptable the oral nutritional supplement is to the child and their parent/carer, including taste, texture, ease of use, etc. | 4 weeks (28 days) |
| Anthropometry | Changes to weight, height and head circumference in children less than 2yrs of age. | 4 weeks (28 days) |
| Safety assessed by adverse events, to be recorded throughout study. | 4 weeks (28 days) |