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Randomised, controlled, open label, cross-over trial to evaluate the tolerance of a new paediatric sip feed in children in need of oral nutritional support.


- candidate number8089
- NTR NumberNTR2340
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mei-2010
- Secondary IDsPed.1.C/J Danone Research – Centre for Specialised Nutrition
- Public TitleRandomised, controlled, open label, cross-over trial to evaluate the tolerance of a new paediatric sip feed in children in need of oral nutritional support.
- Scientific TitleRandomised, controlled, open label, cross-over trial to evaluate the tolerance of a new paediatric sip feed in children in need of oral nutritional support.
- ACRONYMPAT-trial
- hypothesisTolerance of the new paediatric sip feed is equal to the standard paediatric sip feed.
- Healt Condition(s) or Problem(s) studiedChildren, Oral nutritional support
- Inclusion criteria1. 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).
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-mei-2010
- planned closingdate1-dec-2010
- Target number of participants28
- InterventionsTest-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.
- Primary outcomeTolerance: Daily stool frequency (with diary) and frequency and intensity of gastro-intestinal symptoms (with questionnaire).
- Secondary outcome1. Product appreciation: Overall liking and product evaluation carer (both with questionnaire);
2. Daily study product intake (with diary).
- Timepoints1. Visit 1 Baseline (Day 0);
2. Visit 2 (Day 21);
3. Visit 3 (Day 42);
4. Follow-up.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Heidi Sonnemans
- CONTACT for SCIENTIFIC QUERIES Annemiek Goedhart
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD27-mei-2010 - 10-jun-2010


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