Prevention of Respiratory Infections and MAnagement among Children (PRIMAKid).
Completed
- Conditions
- recurrent upper and lower respiratory tract infections (RTI).
- Registration Number
- NL-OMON27299
- Lead Sponsor
- The Netherlands Organization for Health Research and Development ZONMW (grant number 2200.0121)
- Brief Summary
Schonbeck Y, Sanders EA, Hoes AW, Schilder AG, Verheij TJ, Hak E. <br> Rationale and design of the prevention of respiratory infections and management in children (PRIMAKid) study: a randomized controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections.<br> Vaccine. 2005 Sep 30;23(41):4906-14
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 660
Inclusion Criteria
1. Age 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;
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.