Budesonide delivered by dosimetric jet nebulization to preterm very low birthweight infants at high risk for development of chronic lung disease

We investigated the effect of an aerosolized corticosteroid (budesonide) on the oxygen requirement of infants at high risk for developing chronic lung disease (CLD) in a randomized, double-blind study. The study objective was to attain a 30% decrease in FiO(2) levels in the budesonide treatment grou p after 14 d of therapy. Thirty very low birthweight (VLBW) infants (median (range)) gestational age 26 wk (23-29) and birthweight 805 g (525-1227) we re randomized. Inclusion criteria were mechanical ventilation on day 6 of l ife, or if extubated on nasal continuous positive airway pressure with FiO( 2) greater than or equal to 0.3. The budesonide (Pulmicort(TM)) dose was 50 0 mug bid, or placebo. The aerosol was delivered with a dosimetric jet nebu lizer, with variable inspiratory time and breath sensitivity. Inhalations w ere started on day 7 of life. Twenty-seven patients completed the study. A significant lowering of the FiO(2) levels at 21 d of Life was not detected. Infants who received budesonide were more often extubated during the study period (7/8 vs 2/9) and had a greater relative change from baseline in the ir oxygenation index (budesonide decreased 26% vs placebo increased 60%). S ubsequent use of intravenous dexamethasone or inhaled budesonide in the tre atment group was significantly less. All patients required O-2 supplementat ion on day 28 of life. At 36 wk postconceptual age, 61% of infants in the b udesonide group needed supplemental O-2 as opposed to 79% in the placebo gr oup. No side effects on growth or adrenal function were observed. Conclusion: We conclude that inhaled budesonide aerosol via dosimetric jet nebulizer started on day 7 of life for infants at high risk for developing CLD decreases the need for mechanical ventilation similar to intravenous de xamethasone, but without significant side effects.