EFFECTIVENESS OF BUDESONIDE AEROSOL IN VENTILATOR-DEPENDENT PRETERM BABIES - A PRELIMINARY-REPORT

The aim of this randomized, double-blind, placebo-controlled trial was to assess the short-term effect of a topical glucocorticoid (budesoni de 600 mu g twice daily) vs. placebo administered by metered dose inha ler (MDI) and spacer (Aerochamber MV15) directly into the endotracheal tube of intubated infants for 7 days. Twenty preterm infants (mean bi rthweight, 1,030 g; mean gestational age, 27.3 weeks) who still needed assisted ventilation at 14 days of age were randomly assigned to rece ive budesonide (n = 9) or placebo (n = 11) and completed the study. Th e primary outcome was the need for mechanical ventilation after 7 days of treatment. Other outcome variables included ventilator settings, b lood gases, serum cortisol levels, and bronchoalveolar ravage inflamma tory cell counts. No ventilated infant was extubated during the study period. The treatment group showed significant improvements in mean pe ak inspiratory pressure, ventilator efficiency index, and (A-a) oxygen difference. There were no changes in the placebo group. Serum cortiso l levels and bronchoalveolar lavage cell counts did not change signifi cantly during the study period. There was no difference in side effect s between the groups. This trial demonstrates that topical budesonide administered by MDI and Aerochamber produces clinical improvement in v entilated preterm infants, without glucocorticoid side effects. (C) 19 96 Wiley-Liss, Inc.