Acute respiratory infections Infant
Conditions
Interventions
The study consists of 28 children in the intervention group to receive broncho vaxom , 1 capsule daily for 10 days every month for 3 consecutive months and 27 children in the placebo group. Participan
Drug
HP3.073.433.101
Sponsors
Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Eligibility
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: Both female and male children 1 to 5 years old; daycare or preschool attendance; written informed consent signed and dated by a parent or legal guardian in accordance with the ethical standards of the local ethics research committee.
Exclusion criteria
Exclusion criteria: Children diagnosed with asthma, cystic fibrosis, major systemic condition, immune disorders, suspected malabsorption, known allergy to bacterial extracts, major surgery within 3 months of study entry, recent immunosuppressive, immunostimulant or corticosteroid therapy or any other chronic disease that might affect the results; premature babies (less 36 weeks gestation); children participating in other research studies during this project; children who have received OM-85 or any other immunostimulatory or immunosuppressive agents including cyclosporine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the number of respiratory infections (rhinopharyngitis, otitis, sinusitis and pneumonia) in the 06-month period, verified by telephone survey, based on a 50% reduction in the mean number of recurrent respiratory infections in the treated group compared to the placebo group.;There was no significant difference in the number of respiratory infections in both groups.The mean in the group receiving OM-85 BV in the first 3 months was 0.92 ± 0.87 and in the placebo group was 0.74 ± 1.02 (p = 0.26) and at 6 months it was 1.62 ± 1.47 and 1.03 ± 1.34, respectively (p = 0.94). | — |
Secondary
| Measure | Time frame |
|---|---|
| Episodes of wheezing, use of antibiotics, hospital admission and emergency consultations during the 06-month period verified by telephone inquiry.;There was no significant difference in relation to episodes of wheezing, antibiotic use, hospitalization and emergency consultations among the 02 groups. The mean number of visits to the emergency room in the first 3 months was 0.81 ± 1.21 in the OM-85 BV group (p = 0.17) and 1.29 ± 1.48 in the placebo group and at 6 months was 1.77 ± 1, 80 in the OM-85 BV group and 2.03 ± 1.76 in the placebo group (p = 0.58). Antibiotic was used in 10 (37%) children of the OM-85BV group in the 3 months of treatment and in 13 (48.1%) of the placebo group (p = 0.58), and in the 6 months of follow-up the use was 48.1% in both groups (p = 1.00). The mean number of hospitalizations was very low in the study period, with no statistical significance, but only 1 child in the OM-85 BV group was hospitalized in the 6-month period and 3 (11.1%) in the placebo group (p = 0.23 at 3 months and p = 0.61 at 6 months). The incidence of wheezing was equal in both groups, occurring in 5 (18.5%) children in the 3 months of treatment (p = 1.00) and 7 (25.9%) in the 6 months of follow-up (p = 1.00). | — |
Countries
Brazil
Contacts
Public ContactLeonardo Pinto
Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Outcome results
None listed