Tolerance of the new paediatric sip feed is equal to the standard paediatric sip feed.
ID
Bron
Verkorte titel
Aandoening
Children in need of oral nutritional support
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Tolerance: Daily stool frequency (with diary) and frequency and intensity of gastro-intestinal symptoms (with questionnaire).
Achtergrond van het onderzoek
In this trial the tolerance, appreciation and compliance of a new fibre-enriched paediatric sip feed will be compared with a standard fibre-enriched paediatric sip feed in children in need of oral nutritional support.
Doel van het onderzoek
Tolerance of the new paediatric sip feed is equal to the standard paediatric sip feed.
Onderzoeksopzet
1. Visit 1 Baseline (Day 0);
2. Visit 2 (Day 21);
3. Visit 3 (Day 42);
4. Follow-up.
Onderzoeksproduct en/of interventie
Test-product: A new paediatric sip feed that is nutritionally complete and energy dense (1.5 kcal/ml). Amount: As pre-scribed by Health Care Professional.
Control-product: A standard fibre-enriched paediatric sip-feed that is already on the market. Amount: As pre-scribed by Health Care Professional.
Publiek
Heidi Sonnemans
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
heidi.sonnemans@danone.com
Wetenschappelijk
Heidi Sonnemans
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
heidi.sonnemans@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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);
2. Subject requires a paediatric sip feed for at least 6 weeks;
3. Both hospitalized subjects and out-patients;
4. Stable health status and expected to remain stable throughout the study (in the opinion of the Health Care Professional);
5. Written informed consent from parents/guardian and subject (if applicable according to local law).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Cow’s milk allergy, known inflammatory bowel diseases, bowel resection;
2. Subjects requiring a fibre-free diet;
3. Known allergy for fruit (apple, pear, strawberry, raspberry, banana, apricot, lemon) and/or carrot;
4. Subjects requiring an adult rather than a paediatric sip feed;
5. Major renal dysfunction (if requiring, but not yet receiving, dialysis);
6. Major hepatic dysfunction (e.g. hepatitis, congenital abnormalities affecting the liver);
7. Major gastrointestinal intolerance (e.g. vomiting, diarrhoea);
8. Inherited metabolic disorders, including galactosaemia;
9. Use of parenteral feeding and/or enteral tube-feeding;
10. Investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements;
11. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL2215 |
NTR-old | NTR2340 |
Ander register | Danone Research – Centre for Specialised Nutrition : Ped.1.C/J |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |