Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial.

Area of Science:

• Global Health
• Pediatric Medicine
• Infectious Disease Prevention

Background:

• Biannual mass azithromycin distribution in children reduces mortality.
• Neonatal administration of azithromycin has not been studied due to safety concerns, specifically infantile hypertrophic pyloric stenosis (IHPS).

Purpose of the Study:

• To evaluate the efficacy and safety of a single oral dose of azithromycin in newborns for preventing child mortality.
• To assess the risk of IHPS following neonatal azithromycin administration.

Main Methods:

• The Nouveaux-nés et Azithromycine: une Innovation dans le Traitement des Enfants (NAITRE) study is a double-masked, randomized, placebo-controlled trial.
• 21,712 newborns aged 8-27 days received either azithromycin (20 mg/kg) or placebo.
• Participants are monitored for adverse events, including IHPS, with all-cause mortality as the primary outcome at 6 months.

Main Results:

• This is a pre-results report; final data analysis is pending.
• The trial is registered under NCT03682653.

Conclusions:

• The NAITRE study will provide crucial data on the safety and efficacy of neonatal azithromycin for mortality reduction.
• Findings will inform public health strategies for newborn care in high-mortality settings.