The primary objective of this study is to evaluate the tolerance of a new smoothie-style paediatric sip feed compared to a standard paediatric sip feed for a period of 6 weeks in children in need of oral nutritional support. The secondary objectives…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
ondervoeding en andere redenen waarom een kind niet (genoeg) groeit.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Oral nutritional support can improve the nutritional status of paediatric
patients but compliance may be problematic. Danone has developed a new
smoothie-style paediatric sip feed, to add variety to the current milk-style
paediatric sip feeds.
Formulae with a composition very similar to new smoothie-style paediatric sip
feed have been shown to be well-tolerated and to result in weight gain, linear
growth and maintenance of micronutrient status.
The osmolality of the new sip feed is classified as very high according to the
classification by Zenk (1978). Although no adverse side effects are expected,
the tolerance will be examined in this study for safety aspects.
This study will be performed with children as it is best to examine the
tolerance in the group of subjects the product is intended for. Furthermore,
differences in tolerance cannot be excluded between children and adults, due to
physiological reasons.
Study objective
The primary objective of this study is to evaluate the tolerance of a new
smoothie-style paediatric sip feed compared to a standard paediatric sip feed
for a period of 6 weeks in children in need of oral nutritional support.
The secondary objectives of this study are to evaluate the appreciation of and
compliance to a new smoothie-style paediatric sip feed compared to a standard
paediatric sip feed for a period of 6 weeks in children in need of oral
nutritional support.
Study design
This is a randomised, controlled, open-label, cross-over, multi-centre,
multi-country study.
Intervention
- the new smoothie-style paediatric sip feed during 3 weeks
- the standard paediatric sip feed during 3 weeks
Study burden and risks
The burden for the subject is limited and the expected risks are low.
The burden for the subject consists of:
- Completion of a diary during 6 weeks. In this diary the subject/parents
should document the daily stool and the daily intake of study product. The
diary includes a prodcut appreciation questionnaire (3 questions, to be filled
in 6 times), and a tolerance questionnaire (to be filled in 6 times).
- 2 x completion of a 3-day food diary.
- In case consent is given for blood collection: 3 times extra during regular
blood drawing.
If adverse side effects do occur after drinking the smoothie-style sip feed,
these are expected to be mild and acceptable for the subjects.
Postbus 7005
6700 CA Wageningen
NL
Postbus 7005
6700 CA Wageningen
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31053.094.09 |