We conducted a double-blind, randomized controlled trial to assess the efficacy of a combination of prophylactic systemic dexamethasone (SD) and nebulized budesonide (NB) in reducing the incidence and severity of chronic lung disease (CLD) in VLBW infants at risk. Fifty-nine ventilator-dependent infants < 30 wks and ≤ 1500 g were assigned to receive either steroids(S) or saline placebo as of 7 d of age. The S group (n=30, GA=25.8±1.6 wks, BW=731±144 g) received SD 0.25 mg/kg twice daily for 3 days, followed by NB 500 μg twice daily for 18 days. Control infants (n=29, GA=25.9±1.8 wks, BW=796±199 g) received systemic and inhaled saline.
Survival to discharge was similar in the 2 groups (73.3% vs. 82.8% in controls). Infants on S required less ventilatory support between 9 and 17 d of age (p ≤ 0.01) and less supplemental O2 between 8 and 10 d of age(p < 0.05), and had better pulmonary compliance at 10 d of age (p = 0.01). However, these differences were not maintained over the ensuing weeks. Elastase/albumin ratios in the tracheal effluents were similar in the 2 groups during the first month of life. Fewer S infants required late rescue therapy with SD (23.3% vs. 55.2% in controls, p = 0.017). There were no significant differences in timing of extubation (median 39.8 d vs. 38.5 d in controls), and of discontinuation of supplemental O2 in survivors (64.3 ± 33.3 d vs. 74.7 ± 43.3 d in controls). The incidence of CLD at 36 weeks in survivors was 45.5% vs. 54.2% in controls (p=0.77), and length of hospital stay was similar. No steroid-related adverse effects were noted in the S group, other than transient glycosuria. Serial serum cortisol and plasma ACTH values during the treatment period were similar in the 2 groups.
