EARLY ADMINISTRATION OF BECLOMETHASONE IN PREMATURE NEONATES AT RISK FOR BPD

$1,624M01FY2001RRNIH

University Of Utah, Salt Lake City UT

Investigators

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Abstract

The specific aims of this randomized, double-blinded, placebo-controlled study are: 1) evaluate and compare the total duration of mechanical ventilation in the proportion of infants extubated on day 30, following a 14-day course of inhaled beclomethasone or placebo initiated within the first five days of life and; 2) measure the effect of inhaled beclomethasone on markers of pulmonary inflammation, including tracheobronchial effluent cell cytology, and concentrations of elastase, Interleukin-8, and albumin. Twenty-seven patients have been enrolled on this study, but analysis will not begin until a sufficient number of patients (approximately 66) have been ascertained. The sample size calculation was based on a 35% minimal detectable difference in the proportion of patients extubated by post-natal day 30. An important part of this project is to determine long-term outcome measures. Outcomes to be analyzed include development of intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, and nosocomial infections.

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