Abstract 1932

BPD represents the most common form of chronic infant lung disease. Exogenous surfactant has not altered the overall incidence of BPD but, rather, has resulted in a frame shift towards a more premature affected population. BPD is associated with enormous medical, financial and emotional costs. Intravenous dexamethasone initiated at birth has been reported to eliminate BPD, but continuing concerns about systemic side effects of intravenous steroids prompted the current investigation targeting the pulmonary inflammatory pathophysiology associated with BPD. Meter-dosed inhaled BEC was administered by bag ventilation utilizing an aerosolization chamber and a tapering-dose schedule beginning at birth and continued over the first 12 days of life. Study design was a prospective, double-blinded, placebo-controlled trial, reviewed and approved by 2 human subjects committees. Nineteen placebo-treated and 20 BEC-treated infants completed the study in term of evaluation for BPD at 32 weeks corrected gestational age (CGA).

Study Demographics (Placebo/BEC): Gestational age, 26±2/26±2 (weeks); birth weight, 802±25/910±198 (g); male:female ratio, 44:36/60:40; Black:Caucasian ratio, 63:37/70:25; antenatal steroids, 79%/70%; pulmonary surfactant, 95%/80%.

Outcome Variables (Placebo/BEC): FiO2 @ 24 hrs of age, 0.31±0.14/0.32±0.17; Total NICU days, 85±25/75±21 (p=0.19); NICU O2 days, 78±32/68±26 (p=0.29); Mechanical ventilation days, 37±19/20±16 (p=0.0042); CPAP days, 6±8/16±12 (p=0.0048); O2 @ 30 days, 100%/65% (p=0.0050); O2 @ 36 weeks CGA, 68%/50% (p=0.243) No differences between groups were noted for the diagnoses of retinopathy of prematurity, infectious disease, or intraventricular hemorrhage. No differences in adrenal cosyntropin stimulation tests were ascertained between placebo and BEC-treated infants. No BEC adverse effects were observed. Inhaled BEC initiated at birth may decrease the need for mechanical ventilation in premature infants at risk for BPD. BEC appears to reduce the need for oxygen at 30 days. In this investigation where a type 2 error may be likely, no reduction in the need for O2 at 36 weeks CGA was noted for BEC-treated neonates. Additional clinical investigations, with larger number of subjects, examining the potential benefit of inhaled steroids beginning at birth to attenuate the incidence and severity of BPD are warranted.

Funded by UW GCRC (M01RR03186) UW SCORE (P50HL46478) Glaxo Wellcome Research and Development, Eleanor Naylor Charitable Trust and Thrasher Research Fund