Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial. Issue 9 (4th September 2019)

• Record Type: Journal Article
• Authors: Sie, Ali; Bountogo, Mamadou; Nebie, Eric; Ouattara, Mamadou; Coulibaly, Boubacar; Bagagnan, Cheik; Zabre, Pascal; Lebas, Elodie; Brogdon, Jessica; Godwin, William W; Lin, Ying; Porco, Travis; Doan, Thuy; Lietman, Thomas M; Oldenburg, Catherine E
• Other Names: author non-byline.; Sie Ali author non-byline.; Bountogo Mamadou author non-byline.; Ouattara Mamadou author non-byline.; Coulibaly Boubacar author non-byline.; Bagagnan Cheik author non-byline.; Zakane Alphonse author non-byline.; Compaoré Guillaume author non-byline.; Boudo Valentin author non-byline.; Ouermi Lucienne author non-byline.; Ouedraogo Aristide author non-byline.; Thierry Ouedraogo Andiyam author non-byline.; Nebie Eric author non-byline.; Napon A.M. author non-byline.; Nikièma Z. author non-byline.; Hightower Allen author non-byline.; Abdou Amza author non-byline.; Laufer Miriam author non-byline.; Glover Jacqueline author non-byline.; Fawzi Wafaie author non-byline.; Brogdon Jessica author non-byline.; Cook Catherine author non-byline.; Doan Thuy author non-byline.; Godwin William W. author non-byline.; Keenan Jeremy D. author non-byline.; Lebas Elodie author non-byline.; Lietman Thomas M. author non-byline.; Lin Ying author non-byline.; O'Brien Kieran S. author non-byline.; Oldenburg Catherine E. author non-byline.; Porco Travis C. author non-byline.; Bärnighausen Till author non-byline.;
• Is Part Of: BMJ open. Volume 9:Issue 9(2019)
• Publication Date: 2019-09-04
• Subjects: azithromycin -- neonatal mortality -- sub-Saharan Africa -- randomised controlled trial; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-031162
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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.