A randomized placebo-controlled study to evaluate the effects of oral albuterol on pulmonary mechanics in ventilator-dependent infants at risk of developing BPD.

Albuterol is a specific beta-2 agonist that has been reported to be effective in treating infants and children with bronchospastic pulmonary disease. The use of oral albuterol has not been investigated in patients with bronchopulmonary dysplasia (BPD). Thirty premature infants were randomized to receive oral albuterol (0.15 mg/kg/dose q8h) or a volume- and color-matched placebo (D5/W). Pulmonary functions were evaluated at baseline and at 48 and 96 hours after entry to the study. The study was also designed for crossover from placebo to albuterol or albuterol to caffeine in the event that the infant's total pulmonary resistance did not improve at the time of the 48 hour pulmonary function evaluation. Heart rate and respiratory rate showed a statistically significant but clinically unimportant increase in the albuterol-treated infants. There were no significant differences noted in systolic or diastolic blood pressure. Percent improvement in the pulmonary function indices were calculated from baseline to 48 hours and from baseline to 96 hours for the placebo and albuterol-treated groups. The results indicate that at 48 hours there were statistically significant improvements in total resistance (14.5%), inspiratory resistance (10.8%), and expiratory resistance (12.9%) in the albuterol-treated infants as compared to the spontaneous deterioration of the same values by 25%, 81%, and 11%, respectively, in the placebo-treated infants. In conclusion, oral albuterol therapy of 48 hours duration improved pulmonary resistance without major cardiovascular side effects in ventilator-dependent premature infants.

RCT Entities:   Population Interventions Outcomes