Single arm, open label, multi-centre intervention trial to evaluate the tolerance and acceptability of a high energy, nutrient enriched infant formula.
- Conditions
- malnutrition, failure to thrive
- Registration Number
- NL-OMON27027
- Lead Sponsor
- Danone Research – Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Age 0 to 18 months (including 0 and 18 months);
2. 37 to 42 weeks gestation at birth;
Exclusion Criteria
1. Body weight > 9kg;
2. Proven cow‟s milk allergy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerance and acceptability.
- Secondary Outcome Measures
Name Time Method Safety parameters:<br /><br>1. Occurrence of (serious) adverse events.<br /><br>Other parameters:<br /><br>2. Compliance (daily current and new formula intake);<br /><br>3. Convenience (convenience questionnaire).