The effect of early nutrition in high-risk infants on allergy prevention during the first 12 months of life
Not Applicable
Completed
- Conditions
- Atopic diseaseSkin and Connective Tissue DiseasesAtopic dermatitis
- Registration Number
- ISRCTN65195597
- Lead Sponsor
- umico Research BV (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1200
Inclusion Criteria
1. Newborn infants
2. High risk classification for atopic disease (at lease one of the parents with documented allergic disease)
Exclusion Criteria
1. Premature delivery
2. Twins
3. Neonatal illnesses
4. Significant congenital abnormalities
5. Intake of cow's milk based formula before randomisation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence of AEDS. Diagnosis according to modified Hanifin and Rajka criteria and SCORAD index of 10 or higher.
- Secondary Outcome Measures
Name Time Method 1. Severity and course of AEDS<br>2. Gastro-intestinal tract characteristics<br>3. Faecal microbiota<br>4. Immunological blood parameters