Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial.
azithromycin
neonatal mortality
randomised controlled trial
sub-Saharan Africa
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
04 09 2019
04 09 2019
Historique:
entrez:
7
9
2019
pubmed:
7
9
2019
medline:
2
10
2020
Statut:
epublish
Résumé
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. The 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. NCT03682653; Pre-results.
Identifiants
pubmed: 31488494
pii: bmjopen-2019-031162
doi: 10.1136/bmjopen-2019-031162
pmc: PMC6731835
doi:
Substances chimiques
Anti-Bacterial Agents
0
Azithromycin
83905-01-5
Banques de données
ClinicalTrials.gov
['NCT03682653']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e031162Subventions
Organisme : NIMH NIH HHS
ID : R25 MH083620
Pays : United States
Investigateurs
Ali Sie
(A)
Mamadou Bountogo
(M)
Mamadou Ouattara
(M)
Boubacar Coulibaly
(B)
Cheik Bagagnan
(C)
Alphonse Zakane
(A)
Guillaume Compaoré
(G)
Valentin Boudo
(V)
Lucienne Ouermi
(L)
Aristide Ouedraogo
(A)
Ouedraogo Andiyam Thierry
(OA)
Eric Nebie
(E)
A M Napon
(AM)
Z Nikièma
(Z)
Allen Hightower
(A)
Amza Abdou
(A)
Miriam Laufer
(M)
Jacqueline Glover
(J)
Wafaie Fawzi
(W)
Jessica Brogdon
(J)
Catherine Cook
(C)
Thuy Doan
(T)
William W Godwin
(WW)
Jeremy D Keenan
(JD)
Elodie Lebas
(E)
Thomas M Lietman
(TM)
Ying Lin
(Y)
Kieran S O'Brien
(KS)
Catherine E Oldenburg
(CE)
Travis C Porco
(TC)
Till Bärnighausen
(T)
Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: Study medication (azithromycin and placebo) are donated by Pfizer (New York, NY).
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