Asthma, a disease due to a lack of bacterial infections in childhood.
Completed
- Conditions
- A randomised single-blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo.
- Registration Number
- NL-OMON20850
- Lead Sponsor
- Dutch Organisation for Scientific Research (NWO) and Netherlands Asthma Foundation (NWO-NAF 3.2.93.96.2)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
High-risk newborns. High-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.
Exclusion Criteria
1. Maternal infection in the last week of pregnancy;
2. The use of immunomodulatory drugs or antibiotics during pregnancy (mother);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of atopic disease at the age of 4 years.
- Secondary Outcome Measures
Name Time Method 1. SCORAD;<br /><br>2. Lung function;<br /><br>3. Cytokine production;<br /><br>4. NRAMP-polymorphisms.