Study Design and Setting
This interventional, single-center, blinded, placebo-controlled,
multiple-crossover randomized trial was designed to examine the
short-term tolerability and efficacy of two different doses of
aerosolized albuterol: 1.25 mg and 2.5 mg. Aerosolized normal saline was
used as the placebo control. The trial was conducted in the Neonatal and
Infant Intensive Care Unit (N/IICU) at the Children’s Hospital of
Philadelphia (CHOP) between August 2016 and June 2018. The CHOP N/IICU
is a quaternary referral center that primarily cares for outborn infants
who require higher levels of intensive care. This study was approved by
the Institutional Review Board at CHOP. Parental informed consent was
obtained for all enrolled infants.