[4515.3] Use of Azithromycin for the Early Treatment of Ureaplasma spp. in Preterm Infants: A Randomized, Double-Blind, Placebo Controlled Trial

H.O. Ballard, P. Bernard, V. Whitehead, D. Grider, J. England, M. Tucker, L. Shook. Pediatrics, University of Kentucky, Lexington, KY.

BACKGROUND: The causative role of Ureaplasma spp. in the development of bronchopulmonary dysplasia (BPD) remains unclear. Since preventive therapies for BPD are limited and Ureaplasma spp. may be associated with BPD, we attempted to treat preterm infants with azithromycin.
OBJECTIVE: The purpose of this study was to evaluate if treatment of preterm neonates with azithromycin was effective in eradicating Ureaplasma spp. and reducing the incidence of BPD.
DESIGN/METHODS: Infants ≤1250 g birth weight admitted to the Neonatal Intensive Care Unit from 9/2004-8/2008 were randomized to azithromycin (A) or placebo (P) within 12 hours of beginning mechanical ventilation and within 72 hours of birth. The A group received azithromycin 10 mg/kg/day for 7 days followed by 5 mg/kg/day for a maximum of 6 weeks or until the infant was extubated and on room air. Aspirates were collected at enrollment, 3 and 7 days after enrollment, and then weekly for up to 6 weeks as long as the infants remained on mechanical ventilation. The primary endpoints were incidence of BPD and mortality. Data were analyzed using Chi-square and ANOVA.
RESULTS: A total of 220 infants were enrolled (n=111 A, and 109 P) and 176 survived to discharge. Mean gestational age and birth weight were similar between groups. The incidence of Ureaplasma spp. was similar between the A and P groups (51% vs. 58%, p=0.27), respectively. When evaluating only infants who had at least 1 or more positive PCRs for Ureaplasma spp. the mortality (19% vs. 20%, p=0.88) and incidence of BPD (60% vs. 69%, p=0.3) did not differ between the A and P groups, respectively. Combining the endpoints BPD and death did not differ between groups (78% vs. 89%, p=0.12), respectively. The chance of 3 or more positive tracheal aspirates for Ureaplasma spp. did not differ between the A and P groups (16% vs. 20%), respectively. The incidence of retinopathy of prematurity, intraventricular hemorrhage, sepsis, and other outcomes associated with preterm birth did not differ between groups.
CONCLUSIONS: Early treatment of Ureaplasma spp. with a 6 week course of azithromycin in preterm infants with birth weight ≤1250 g does not significantly decrease the incidence of bronchopulmonary dysplasia.
E-PAS2009:4515.3

Date: Monday, May 4, 2009
Poster Symposium Session: BPD: Clinical Results (1:00 PM - 3:00 PM)
Presentation Time: 1:00 PM
Room: Ballroom III (posters in lobby) - Baltimore Convention Center
Board Number: 3
Course Number: 4515