Growth Failure
Conditions
Brief summary
This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.
Detailed description
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.
Interventions
OTHERHE ONS
High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management
OTHERSE ONS
Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management
Sponsors
Nutricia UK Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Aged 1-12yrs * Faltering growth and/or requiring oral nutritional supplements to meet nutritional requirements * Expected to receive at least one bottle of the study product per day * Able to take study products orally during the study period * Written informed consent from parent/carer
Exclusion criteria
* Requirement for 100% of their nutrition via enteral tube and/or parenteral feeding. * Children with major hepatic or renal dysfunction * Children with galactosaemia or severe lactose intolerance * Requirement for elemental or semi-elemental feeds * Investigator concern around willingness/ability of child/parent/carer to comply with protocol requirements * Participation in other studies within 2 weeks of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutrient intake | 4 weeks (28 days) | Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 4 weeks (28 days) | Changes to weight, height and head circumference in children less than 2yrs of age. |
| Safety assessed by adverse events, to be recorded throughout study. | 4 weeks (28 days) | — |
Outcome results
None listed