Prevention of Respiratory Infections and MAnagement among Childre
Completed
- Conditions
- Respiratory tract infection (RTI)RespiratoryOther diseases of upper respiratory tract
- Registration Number
- ISRCTN84713819
- Lead Sponsor
- The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 660
Inclusion Criteria
1. Aged between 18 - 72 months
2. A history of two or more episodes of general practitioner attended RTIs
Exclusion Criteria
1. No intention to move within 12 months to another region
2. Provision of informed consent
3. Good mastering of the Dutch language
4. Absence of chronic diseases such as asthma treated with corticosteroids or high-risk disease (such as palatoschisis, Down syndrome, cystic fibrosis, etc)
5. No previous influenza vaccination or pneumococcal vaccination or Hepatitis B vaccination
6. No hypersensitivity to eggs and/or antibiotics, and/or serious history of serious adverse events through vaccination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of febrile RTI episodes
- Secondary Outcome Measures
Name Time Method Severity and length of febrile RTI episodes as well as RTI-associated antibiotic prescriptions, medical visits, clinical laboratory diagnostic procedures, specialist referral and treatment with procedures like ventilatory tube placement or adeno-tonsillectomy, improvement of health-related quality of life, and reduced productivity loss of parents. Follow-up time varies from 7 to 22 months.