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Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG)
INTRODUCTION: Increasing evidence suggests that the BCG vaccine has non-specific effects, altering the susceptibility to non-tuberculous infections. Thus, early BCG vaccination may reduce mortality. BCG is recommended at birth but is often delayed. Vaccination opportunities are missed due to multido...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9680145/ https://www.ncbi.nlm.nih.gov/pubmed/36410811 http://dx.doi.org/10.1136/bmjopen-2022-063872 |
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author | Thysen, Sanne Marie Møller Jensen, Andreas Vedel, Julie Odgaard da Silva Borges, Igualdino Aaby, Peter Jensen, Aksel Karl Georg Benn, Christine Stabell Fisker, Ane Bærent |
author_facet | Thysen, Sanne Marie Møller Jensen, Andreas Vedel, Julie Odgaard da Silva Borges, Igualdino Aaby, Peter Jensen, Aksel Karl Georg Benn, Christine Stabell Fisker, Ane Bærent |
author_sort | Thysen, Sanne Marie |
collection | PubMed |
description | INTRODUCTION: Increasing evidence suggests that the BCG vaccine has non-specific effects, altering the susceptibility to non-tuberculous infections. Thus, early BCG vaccination may reduce mortality. BCG is recommended at birth but is often delayed. Vaccination opportunities are missed due to multidose vials not being opened for a few children. We will assess the effect of making BCG available at the first health-facility contact on early infant mortality and morbidity in a rural setting in Guinea-Bissau. METHODS AND ANALYSIS: In a cluster-randomised crossover trial, we randomise 23 health centres to two different treatment groups. In half of the health centres, BCG is provided as per current practice; in the remaining health centres, we make BCG available everyday to allow opening a vial of BCG if there is just one eligible child present. The randomisation of centres will be crossed over after 12 months and enrolment will continue for another 12 months. We will use logistic regression models with adjustment for village to assess the effect of making BCG available at the first health-facility contact. The main outcome is non-accidental mortality between day 1 and day 42 after birth. We will adjust for sex, health centre, period (before/after crossover) and level of surveillance (level 1 or level 2). Further analyses include assessment of the effect on hospital admission and a cost-effectiveness evaluation. ETHICS AND DISSEMINATION: If BCG vaccination reduces early infant mortality, missed opportunities and delays of vaccinations expose infants in several low-income countries to unnecessary excess mortality risk. The present trial will provide information on the effect of implementing a feasible intervention, where all children receive BCG at their first health-facility contact. Consent is obtained from all pregnant women registered as part of the trial. The results of the study will be published and communicated to the National Institute of Public Health in Guinea-Bissau. TRIAL REGISTRATION NUMBER: NCT04658680; Clinicaltrials.gov. |
format | Online Article Text |
id | pubmed-9680145 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-96801452022-11-23 Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG) Thysen, Sanne Marie Møller Jensen, Andreas Vedel, Julie Odgaard da Silva Borges, Igualdino Aaby, Peter Jensen, Aksel Karl Georg Benn, Christine Stabell Fisker, Ane Bærent BMJ Open Global Health INTRODUCTION: Increasing evidence suggests that the BCG vaccine has non-specific effects, altering the susceptibility to non-tuberculous infections. Thus, early BCG vaccination may reduce mortality. BCG is recommended at birth but is often delayed. Vaccination opportunities are missed due to multidose vials not being opened for a few children. We will assess the effect of making BCG available at the first health-facility contact on early infant mortality and morbidity in a rural setting in Guinea-Bissau. METHODS AND ANALYSIS: In a cluster-randomised crossover trial, we randomise 23 health centres to two different treatment groups. In half of the health centres, BCG is provided as per current practice; in the remaining health centres, we make BCG available everyday to allow opening a vial of BCG if there is just one eligible child present. The randomisation of centres will be crossed over after 12 months and enrolment will continue for another 12 months. We will use logistic regression models with adjustment for village to assess the effect of making BCG available at the first health-facility contact. The main outcome is non-accidental mortality between day 1 and day 42 after birth. We will adjust for sex, health centre, period (before/after crossover) and level of surveillance (level 1 or level 2). Further analyses include assessment of the effect on hospital admission and a cost-effectiveness evaluation. ETHICS AND DISSEMINATION: If BCG vaccination reduces early infant mortality, missed opportunities and delays of vaccinations expose infants in several low-income countries to unnecessary excess mortality risk. The present trial will provide information on the effect of implementing a feasible intervention, where all children receive BCG at their first health-facility contact. Consent is obtained from all pregnant women registered as part of the trial. The results of the study will be published and communicated to the National Institute of Public Health in Guinea-Bissau. TRIAL REGISTRATION NUMBER: NCT04658680; Clinicaltrials.gov. BMJ Publishing Group 2022-11-21 /pmc/articles/PMC9680145/ /pubmed/36410811 http://dx.doi.org/10.1136/bmjopen-2022-063872 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Global Health Thysen, Sanne Marie Møller Jensen, Andreas Vedel, Julie Odgaard da Silva Borges, Igualdino Aaby, Peter Jensen, Aksel Karl Georg Benn, Christine Stabell Fisker, Ane Bærent Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG) |
title | Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG) |
title_full | Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG) |
title_fullStr | Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG) |
title_full_unstemmed | Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG) |
title_short | Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG) |
title_sort | can bcg vaccination at first health-facility contact reduce early infant mortality? study protocol for a cluster-randomised trial (cs-bcg) |
topic | Global Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9680145/ https://www.ncbi.nlm.nih.gov/pubmed/36410811 http://dx.doi.org/10.1136/bmjopen-2022-063872 |
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