Effects of a nutrient dense infant formula on the growth and tolerance of infants compared to current practice in Spain.
Completed
- Conditions
- (non-) organic growth failure
- Registration Number
- NL-OMON29641
- Lead Sponsor
- umico Research B.V.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Infants aged 0 to 9 months;
2. Infants with increased energy requirements and/or fluid restrictions and/or with indication for using high-energy feeds;
Exclusion Criteria
1. Infants with cow's milk intolerance, major gastrointestinal hepatic or renal dysfunction, or inherited metabolic disorders including galactosaemia are excluded for this study;
2. Investigator's uncertainty about the willingness or ability of the caretaker to comply with the protocol requirements;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase in Z-score for length at 6 weeks relative to baseline.
- Secondary Outcome Measures
Name Time Method Anthropometrics, gastrointestinal tolerance, fecal microbiology and dietary intake.