[4515.2] Use of Azithromycin for the Prevention of Bronchopulmonary Dysplasia: A Randomized, Double-Blind, Placebo Controlled Trial

Hubert O. Ballard, Phil Bernard, Don Hayes, Michael Anstead, Richard Kryscio, Nirmala Desai, Lori Shook. Pediatrics; Biostatistics, University of Kentucky, Lexington, KY.

BACKGROUND: There is selected evidence that early treatment with azithromycin in extremely low birth weight infants may be beneficial in preventing bronchopulmonary dysplasia (BPD).
OBJECTIVE: The purpose of this study was to evaluate if treatment of preterm neonates with prophylactic azithromycin is effective in 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. Tracheal aspirates for Ureaplasma PCR were collected at the time of enrollment and then weekly. 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 have completed the study. Mean gestational age and birth weight were similar between groups. Mortality (18% vs. 22%, p=0.46) and incidence of BPD (59% vs. 62%, p=0.71) did not differ between the A and P groups. Combining the endpoints BPD and death did not differ between groups (22% vs. 15%, p=0.19), respectively. The table below demonstrates the difference in the severity of BPD based on the NIH classification in survivors (p=0.14):

Table 1: Severity of BPD

NIH Classification of BPD	Azithromycin Group (n=91)	Placebo Group (n=85)
Mild—n (%)	25 (27)	16 (19)
Moderate—n (%)	35 (38)	45 (53)
Severe—n (%)	31 (34)	24 (28)

The incidence of retinopathy of prematurity, intraventricular hemorrhage, sepsis, and other outcomes associated with preterm birth did not differ between groups. No adverse events were noted.
CONCLUSIONS: Azithromycin prophylaxis in preterm infants with birth weight ≤1250 g did not affect survival and/or incidence of BPD, but does appear to be safe for use in preterm infants.
E-PAS2009:4515.2

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: 2
Course Number: 4515