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Published on: January 7, 2020
Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial
Ali Sie1, Mamadou Bountogo1, Eric Nebie1
1Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Insights
This trial investigates if a single oral dose of azithromycin given to newborns can prevent child mortality. Researchers are assessing its safety and effectiveness, particularly concerning infantile hypertrophic pyloric stenosis.
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.
Introduction:
Biannual mass azithromycin distribution to children aged 1-59 months has been shown to reduce all-cause mortality. Children under 28 days of age were not treated in studies evaluating mass azithromycin distribution for child mortality due to concerns related to infantile hypertrophic pyloric stenosis (IHPS). Here, we report the design of a randomised controlled trial to evaluate the efficacy and safety of administration of a single dose of oral azithromycin during the neonatal period.
Methods And Analysis:
The Nouveaux-nés et Azithromycine: une Innovation dans le Traitement des Enfants (NAITRE) study is a double-masked randomised placebo-controlled trial designed to evaluate the efficacy of a single dose of azithromycin (20 mg/kg) for the prevention of child mortality. Newborns (n=21 712) aged 8-27 days weighing at least 2500 g are 1:1 randomised to a single, directly observed, oral dose of azithromycin or matching placebo. Participants are followed weekly for 3 weeks after treatment to screen for adverse events, including IHPS. The primary outcome is all-cause mortality at the 6-month study visit.
Ethics And Dissemination:
This study was approved by the Institutional Review Boards at the University of California, San Francisco in San Francisco, USA (Protocol #18-25027) and the Comité National d'Ethique pour la Recherche in Ouagadougou, Burkina Faso (Protocol #2018-10-123). The findings of this trial will be presented at local, regional and international meetings and published in open access peer-reviewed journals.
Trial Registration Number:
NCT03682653; Pre-results.
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