TRIAL OF BECLOMETHASONE DIPROPIONATE BY METERED-DOSE INHALER IN VENTILATOR-DEPENDENT NEONATES LESS-THAN 1500 GRAMS

Beclomethasone dipropionate administered by metered-dose inhaler to ve ntilated infants with early chronic lung disease was evaluated in a do uble-blind, placebo-controlled study to determine the feasibility and safety of administration. Patients selected for study were less than 1 500 g birthweight, had previous radiographic evidence of respiratory d istress syndrome with early changes of bronchopulmonary dysplasia (BPD ), were greater than 2 weeks of age, and had failed attempts at extuba tion. The metered-dose inhaler was connected to the respirator circuit by an in-line spacer device and either saline placebo or beclomethaso ne was delivered for 7 days or until extubated. Beclomethasone was del ivered in a dose calculated to be approximately 1 mg/kg/day in three d ivided doses. Nineteen infants were enrolled. Nine received placebo an d 10 received beclomethasone. No adverse effects on blood pressure, he art rate, respiratory rate, ventilator settings, concentration or dura tion of oxygen therapy, incidence of retinopathy of prematurity (ROP) or infections, blood glucose, daily weight, or serum cortisol levels b efore and after adrenal stimulation tests were observed in the beclome thasone group compared with the placebo group. One infant in the place bo and six infants in the steroid group were extubated during the stud y period (p = 0.03). These data indicate that beclomethasone dipropion ate may be administered safely to intubated neonates without adverse e ffects of hypertension, hyperglycemia, diminished weight gain, or adre nal suppression frequently seen with systemic steroid administration. Beclomethasone may enhance extubation in infants with early BPD, howev er, further data are required to substantiate this preliminary observa tion.