Abstrakt
Background: There is no strict correlation between early bronchopulmonary dysplasia and long-term respiratory disease. Early inhaled corticosteroids seem to reduce the incidence of bronchopulmonary dysplasia, but the long-term outcome remains unknown.
Research Question: The aim of this study was to evaluate the effect of early inhaled corticosteroids on chronic respiratory morbidity. Methods: Fifty-nine survivors from the Prague cohort included in Neonatal European Study of Inhaled Steroids underwent further follow-up comprising of respiratory morbidity monitoring during the first 2 years of life followed by objective lung function testing performed at the age of 5.9 years (range 5-7 years).
Both outcomes were pursued and finalized before the unblinding of budesonide subgroups. Results: Fifty randomized (budesonide vs placebo group, 56% vs 44%) survivors were included in the study.
Spirometry was successfully performed in 48 children. No statistically significant differences were found in the lung function test (forced expiratory flow [FEF] - FEF75, FEF50, FEF25, and FEF25-75; FEV1, forced vital capacity [FVC], FEV1/FVC) although mild trend to the improvement of expiratory flow pattern was observed in the budesonide group (median z -score of FEV1/FVC -0.376 vs -0.983, P = .13; median z -score of FEF25-75 -1.004 vs -1.458, P = .13; median z -score of FEF75 -0.527 vs -0.996, P = .17).
Children assigned to budesonide had a significantly lower rate of symptoms of chronic lung disease (34.6% vs 68.2%; P = .04) than children assigned to placebo. Interpretation: Our study suggests that early inhaled budesonide was associated with the trend to the improvement of functional lung parameters and with a lower rate of symptoms of chronic lung disease within the first 2 years of life.