Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial
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 py...
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BMJ Publishing Group
2019-09-01
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| Online Access: | https://bmjopen.bmj.com/content/9/9/e031162.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Till Bärnighausen |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b0dbc222085b4d71949ed336bf1cac33 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-09-01 |
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| series | BMJ Open |
| spelling | doaj-art-b0dbc222085b4d71949ed336bf1cac332025-08-20T02:07:32ZengBMJ Publishing GroupBMJ Open2044-60552019-09-019910.1136/bmjopen-2019-031162Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trialTill Bärnighausen0Catherine E Oldenburg1Thomas M Lietman2Thuy Doan3Wafaie Fawzi4Ali Sie5Lucienne Ouermi6Pascal Zabre7Elodie Lebas8Mamadou Bountogo9Eric Nebie10Mamadou Ouattara11Boubacar Coulibaly12Cheik Bagagnan13Jessica Brogdon14William W Godwin15Ying Lin16Travis Porco17Alphonse ZakaneGuillaume Compaoré18Valentin Boudo19Aristide OuedraogoOuedraogo Andiyam ThierryA.M. NaponZ. NikièmaAllen HightowerAmza Abdou20Miriam LauferJacqueline GloverCatherine CookWilliam W. GodwinJeremy D. KeenanThomas M. LietmanKieran S. O’BrienCatherine E. OldenburgTravis C. Porco4 Africa Health Research Institute, KwaZulu-Natal, South AfricaFrancis I. Proctor Foundation, University of California, San Francisco, California, USAFrancis I. Proctor Foundation, UCSF School of Medicine, San Francisco, California, USAFrancis I Proctor Foundation, San Francisco, California, USAGlobal Health and Population, Harvard School of Public Health, Boston, Massachusetts, USA7 Centre de Recherche en Sante de Nouna, Nouna, Boucle du Mouhoun, Burkina FasoCentre de Recherche en Sante de Nouna, Nouna, Burkina Faso2 Centre de Recherche en Sante de Nouna, Nouna, Burkina FasoFrancis I. Proctor Foundation, University of California, San Francisco, California, USA7 Centre de Recherche en Sante de Nouna, Nouna, Boucle du Mouhoun, Burkina Faso1 Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso1 Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso1 Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso1 Centre de Recherche en Sante de Nouna, Nouna, Burkina FasoFrancis I. Proctor Foundation, University of California, San Francisco, California, USA2 Francis I Proctor Foundation, University of California, San Francisco, California, USA1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China2 Francis I Proctor Foundation, University of California, San Francisco, California, USACentre de Recherche en Sante de Nouna, Nouna, Boucle du Mouhoun, Burkina FasoCentre de Recherche en Sante de Nouna, Nouna, Burkina FasoProgramme Nationale de Santé Oculaire, Niamey, NigerIntroduction 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.https://bmjopen.bmj.com/content/9/9/e031162.full |
| spellingShingle | 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 Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial BMJ Open |
| title | Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial |
| title_full | Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial |
| title_fullStr | Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial |
| title_full_unstemmed | Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial |
| title_short | Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial |
| title_sort | neonatal azithromycin administration to prevent infant mortality study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/9/9/e031162.full |
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