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.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR2340
• Date of registration: 27/05/2010
• Primary sponsor: Danone Research B.V.
• Public title: 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.
• Scientific title: 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. - PAT-trial
• Date of first enrolment: 18/5/2010
• Target sample size: 28
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2340
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Crossover; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Annemiek Goedhart

• Name: Heidi Sonnemans

Key inclusion & exclusion criteria

Inclusion criteria: 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).
Exclusion criteria: 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Children, Oral nutritional support

Intervention(s)

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.

Primary Outcome(s)

Tolerance: Daily stool frequency (with diary) and frequency and intensity of gastro-intestinal symptoms (with questionnaire).

Secondary Outcome(s)

1. Product appreciation: Overall liking and product evaluation carer (both with questionnaire);

2. Daily study product intake (with diary).

Secondary ID(s)

Ped.1.C/J

Source(s) of Monetary Support

Danone Research ¨C Centre for Specialised Nutrition