To establish the effect of BCG vaccination in 6 weeks old high-risk infants on the prevalence of asthma and allergic rhinitis at the age of 7 years.
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Asthma, defined by periodic wheezing and dyspnoea, combined with a 9%
reversibility in FEV1 and/or exhaled NO above 20 ppb.
Allergic rhinitis. defined by periodic or perennial sneezing, runny or blocked
nose when not having a cold or the flu.
Secondary outcome
Nitric oxide measurements in nasal air, specific IgE to allergens and
immunologic parameters in serum.
Background summary
The increase in prevalence of allergic diseases in countries with a so-called
Western lifestyle may be due to a decreased exposure to infectious agents in
early life.
Study objective
To establish the effect of BCG vaccination in 6 weeks old high-risk infants on
the prevalence of asthma and allergic rhinitis at the age of 7 years.
Study design
Prospective, single blind, randomised trial.
Study burden and risks
Parents and child are asked to fill in a questionnaire, and pay one visit to
the out patient department for physical examination, blood sampling and
pulmonary function testing with measurement of exhaled nitric oxide. The risks
of these procedures are negligible and the burden minimal. It should be carried
out specifically in these children, since they have been included in the former
study and received placebo or BCG vaccination.
A minimal risk is carried in the discontinuation of the beta-mimetics for a
short period of maximally 48 hours, and of nasal corticosteroids for 6 weeks in
advance of the lung function testing and nasal NO measurements. Participants
might observe an increase in wheezing in the first case, in which case the
advise is to restart the beta-mimetics. The same applies to an exacerbation of
allergic rhinitis, in which case restarting of corticosteroids is adviced or
alternative medication. These risks will be deliberated with the treating
physician, whose advice will be followed by the investigator.
Lundlaan 6
3508 AB Utrecht
Nederland
Lundlaan 6
3508 AB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
participation in study with code WOK 98-24, dd 01-02-1999
Exclusion criteria
no participation in earlier study with code WOK 98-24
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19075.041.07 |