Lower respiratory tract infections and wheezing in moderate-late premature infants
Conditions
Brief summary
Protea-1: Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life., Protea-2: The time to the first lower respiratory episode after 12 months of age.
Detailed description
time to first lower RTI or wheezing episode in the first year of life, total number of RTI in the first and second year of life, total number of wheezing episodes in the first and second year of life, distribution of viruses during lower RTI/wheezing, medication use (bronchodilators, corticosteroids, antibiotics), lung function as measured by expiratory variability index, quality of life, (serious) adverse events (respiratory episodes are not regarded as an (S)AE since they comprise primary and secondary outcomes), serum specific IgE (allergen sensitization) at 12 months, infant vaccination titers at 12 months, costs- and cost-effectiveness
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protea-1: Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life., Protea-2: The time to the first lower respiratory episode after 12 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| time to first lower RTI or wheezing episode in the first year of life, total number of RTI in the first and second year of life, total number of wheezing episodes in the first and second year of life, distribution of viruses during lower RTI/wheezing, medication use (bronchodilators, corticosteroids, antibiotics), lung function as measured by expiratory variability index, quality of life, (serious) adverse events (respiratory episodes are not regarded as an (S)AE since they comprise primary and secondary outcomes), serum specific IgE (allergen sensitization) at 12 months, infant vaccination titers at 12 months, costs- and cost-effectiveness | — |
Countries
Netherlands