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.