Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial
Till Bärnighausen,
Catherine E Oldenburg,
Thomas M Lietman,
Thuy Doan,
Wafaie Fawzi,
Ali Sie,
Lucienne Ouermi,
Pascal Zabre,
Elodie Lebas,
Mamadou Bountogo,
Eric Nebie,
Mamadou Ouattara,
Boubacar Coulibaly,
Cheik Bagagnan,
Jessica Brogdon,
William W Godwin,
Ying Lin,
Travis Porco,
Alphonse Zakane,
Guillaume Compaoré,
Valentin Boudo,
Aristide Ouedraogo,
Ouedraogo Andiyam Thierry,
A.M. Napon,
Z. Nikièma,
Allen Hightower,
Amza Abdou,
Miriam Laufer,
Jacqueline Glover,
Catherine Cook,
William W. Godwin,
Jeremy D. Keenan,
Thomas M. Lietman,
Kieran S. O’Brien,
Catherine E. Oldenburg,
Travis C. Porco
Affiliations
Till Bärnighausen
4 Africa Health Research Institute, KwaZulu-Natal, South Africa
Catherine E Oldenburg
Francis I. Proctor Foundation, University of California, San Francisco, California, USA
Thomas M Lietman
Francis I. Proctor Foundation, UCSF School of Medicine, San Francisco, California, USA
Thuy Doan
Francis I Proctor Foundation, San Francisco, California, USA
Wafaie Fawzi
Global Health and Population, Harvard School of Public Health, Boston, Massachusetts, USA
Ali Sie
7 Centre de Recherche en Sante de Nouna, Nouna, Boucle du Mouhoun, Burkina Faso
Lucienne Ouermi
Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso
Pascal Zabre
2 Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso
Elodie Lebas
Francis I. Proctor Foundation, University of California, San Francisco, California, USA
Mamadou Bountogo
7 Centre de Recherche en Sante de Nouna, Nouna, Boucle du Mouhoun, Burkina Faso
Eric Nebie
1 Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso
Mamadou Ouattara
1 Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso
Boubacar Coulibaly
1 Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso
Cheik Bagagnan
1 Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso
Jessica Brogdon
Francis I. Proctor Foundation, University of California, San Francisco, California, USA
William W Godwin
2 Francis I Proctor Foundation, University of California, San Francisco, California, USA
Ying Lin
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Travis Porco
2 Francis I Proctor Foundation, University of California, San Francisco, California, USA
Alphonse Zakane
Guillaume Compaoré
Centre de Recherche en Sante de Nouna, Nouna, Boucle du Mouhoun, Burkina Faso
Valentin Boudo
Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso
Aristide Ouedraogo
Ouedraogo Andiyam Thierry
A.M. Napon
Z. Nikièma
Allen Hightower
Amza Abdou
Programme Nationale de Santé Oculaire, Niamey, Niger
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.
