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.