Azithromycin Fails to Prevent CLD of Prematurity
TOPLINE:
Prophylactic azithromycin had no significant effect on survival without the development of chronic lung disease (CLD) in high-risk premature infants compared with placebo.
METHODOLOGY:
- The effectiveness of macrolides in preventing CLD in preterm infants has not been examined in large studies, and previous reviews have yielded conflicting evidence.
- The researchers randomized 746 infants born at less than 30 weeks’ gestation who had received at least 2 hours of noninvasive or invasive respiratory support within 72 hours of birth to a placebo or intravenous azithromycin at a dose of 20 mg/kg per day for 3 days and then 10 mg/kg for 7 days.
- The primary outcome was survival without the development of moderate or severe CLD at 36 weeks’ post-menstrual age (PMA); the median gestational age was 27 weeks for both groups.
TAKEAWAY:
- Survival with no development of moderate or severe CLD was similar in the azithromycin and placebo groups (42% and 45%, respectively).
- Rates of moderate or severe CLD was not significantly different between the azithromycin and placebo groups by 36 weeks’ PMA (54% vs 51%; adjusted odds ratio, 0.85) and were not affected by Ureaplasma species colonization or eradication.
- No significant differences appeared between the groups for secondary outcomes including postnatal corticosteroid use, treated patent ductus arteriosus, treated nosocomial infection, intraventricular hemorrhage, or necrotizing enterocolitis.
- A total of 13 serious adverse events were reported, five of which were deemed possibly related to azithromycin.
IN PRACTICE:
“These results suggest that a single intervention during the neonatal period might not be effective; novel strategic combinations of multiple interventional strategies and trial designs are required to address this conundrum,” the researchers wrote.
SOURCE:
The lead author on the study was John Lowe, PhD, of Cardiff University, Cardiff, Wales. This study was published online in The Lancet Respiratory Medicine.
LIMITATIONS:
The findings were limited by several factors including missed oxygen reduction tests, insufficient respiratory support data, and relatively low baseline sampling.
DISCLOSURES:
Lead author Lowe and several coauthors disclosed funding for the study from the National Institute for Health and Care Research Health Technology Assessment program.
