Introduction
Bronchopulmonary dysplasia (BPD) is a frequent complication of prematurity manifested by heterogenous clinical phenotypes and incompletely characterized pathophysiology1,2. One proposed component of disease pathophysiology in established BPD is hyperresponsiveness of the airway smooth muscle3-5. As such, bronchodilators may have therapeutic benefit in some patients6.
Aerosolized albuterol is the most commonly used bronchodilator in infants with severe bronchopulmonary dysplasia (sBPD). As many as one-third of infants with sBPD receive this medication during their hospitalization7-11. Despite these high rates of use, however, there is a paucity of published data on the safety and efficacy of albuterol in this population. While a small number of studies has examined the efficacy of bronchodilator use for the prevention of BPD, the most recent Cochrane review did not identify any suitable randomized trials on its use in infants with established BPD12. Albuterol is also not approved by the US Food and Drug Administration for use in children under 2 years of age.
With the high, ongoing use of albuterol in infants with sBPD, one immediate concern is identifying an appropriate dose for administration and future study in this population. We undertook the present study to evaluate the short-term tolerability and efficacy of two different doses of aerosolized albuterol (1.25 mg and 2.5 mg) in very preterm infants with sBPD receiving invasive mechanical ventilation. We conducted a single-center, multiple cross-over, blinded randomized trial using aerosolized normal saline as a placebo control.