Scientific evidence strongly suggestive of adverse neurodevelopmental effects of systemic dexamethasone appeared in the literature halfway into study enrollment, which prompted us to terminate the trial prematurely after enrollment of 5 infants randomized to beclomethasone and 6 infants to the placebo group.
10,21,22 The subjects were well matched demographically for gestational age and birth weight, as well as Apgar (Activity, Pulse, Grimace, Appearance, Respiration) and SNAP (Score for Neonatal Acute Physiology) scores (
Table 1). Baseline measures of mean airway pressure, dynamic compliance, resistance, and serum and respiratory cytokine levels were also similar at study entry (
Table 2). Measurements of serum as well as respiratory IL-8, IL-1α, and TNF-α were similar between the inhaled corticosteroid and inhaled placebo groups. A representative graph of respiratory and serum TNF-α is presented in
Figures 1 and
2. Respiratory sIL-2R was also not significantly different between the two groups. Due to technical difficulties, we were unable to determine serum sIL-2R levels.
Weekly measurements of dynamic compliance and resistance were similar between the two study groups. There was no difference in the need for subsequent doses of systemic steroids in the two groups. Time to extubation and duration of supplemental oxygen need were also similar between the two groups. There were no increased adverse events recorded with the additional use of inhaled corticosteroids. Infants in both groups had some transient hyperglycemia that resolved after termination of the systemic corticosteroids. All infants are being followed in a developmental follow-up clinic.