ondervoeding en andere redenen waarom een kind niet (genoeg) groeit. Failure to thrive Malnutrition
Conditions
Interventions
- the new smoothie-style paediatric sip feed during 3 weeks
- the standard paediatric sip feed during 3 weeks
Sponsors
Danone Research - Centre for Specialised Nutrition
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: - Male and female subjects, aged 3-12 years (including 3 and 12 years) in need of oral nutritional support (subject can be current or new paediatric sip feed user). - Subject requires a paediatric sip feed for at least 6 weeks. - Both hospitalized subjects and out-patients. - Stable health status and expected to remain stable throughout the study (in the opinion of the Health Care Professional). - Written informed consent from parents/guardian and subject (if applicable according to local law).
Exclusion criteria
Exclusion criteria: - Cow*s milk allergy, known inflammatory bowel disease, bowel resection. - Subjects requiring a fibre-free diet. - Known allergy for fruit (apple, pear, strawberry, raspberry, banana, apricot, lemon) and/or carrot. - Subjects requiring an adult rather than a paediatric sip feed. - Major renal dysfunction (if requiring, but not yet receiving, dialysis). - Major hepatic dysfunction (e.g. hepatitis, congenital abnormalities affecting the liver). - Major gastrointestinal intolerance (e.g. vomiting, diarrhoea). - Inherited metabolic disorders, including galactosaemia. - Use of parenteral feeding and/or enteral tube-feeding. - Investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements. - Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The tolerance parameters in this study are the change between the different interventions in: - Daily stool frequency - Incidence and intensity of the symptoms: belching, nausea, vomiting, flatulence, diarrhoea, constipation, abdominal pain and thirst | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters in this study are: - Product appreciation: Overall liking of the study products and Product evaluation (by carer) - Daily study product intake [% of prescribed] Safety parameters are: - Occurrence of adverse events - Optional: blood sample collection for change in: haematology, electrolytes and kidney function Other study parameters are: - Fluid intake [ml/day] - Dietary intake: total energy [kcal/day] and macronutrients [g/day] - Body weight [kg] - Optional: blood sample collection for markers for nutritional status: serum albumin and serum electrolytes. | — |
Countries
Netherlands
Outcome results
None listed