Effect of azithromycin on mortality in mechanically ventilated preterm babies: A randomized control trial

Objectives: Mechanically ventilated preterm infants are at an increased risk of mortality due to complications related to prematurity and critical illness. Azithromycin has been studied as a potential adjunctive therapy due to its anti-inflammatory, immunomodulatory, and antimicrobial properties, particularly against Ureaplasma species. However, its effect on mortality in ventilated preterm infants remains unclear. The objective is to evaluate the effect of azithromycin on mortality in mechanically ventilated preterm infants. Materials and Methods: Preterm babies who were mechanically ventilated were included in the study. Simple randomization was performed, and the participants were assigned to either the control or intervention group. All neonates received standard care. The intervention group ( n = 37) received azithromycin, while the control group ( n = 37) received saline. The primary outcome was all-cause mortality during hospitalization. Results: No significant differences were observed between the two groups in terms of baseline characteristics, mode of delivery, or duration of mechanical ventilation support. The mortality rates were 47.4% and 43.2% in the azithromycin and control groups, respectively. There was no significant reduction in the mortality rate in the azithromycin group (relative risk [RR] 1.10, 95% confidence interval [CI] 0.67–1.80; p = 0.818). The absolute risk difference was 4.1%. Azithromycin was not associated with mortality even after adjustment for important clinical variables (adjusted RR 0.86, 95% CI 0.43–1.72). Conclusion: Azithromycin administration did not result in a statistically significantly reduce mortality in mechanically ventilated preterm neonates.