Abstract
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 063872 |
| Tidsskrift | BMJ Open |
| Vol/bind | 12 |
| Udgave nummer | 11 |
| Antal sider | 7 |
| ISSN | 2044-6055 |
| DOI | |
| Status | Udgivet - 2022 |
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I: BMJ Open, Bind 12, Nr. 11, 063872, 2022.
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
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TY - JOUR
T1 - Can BCG vaccination at first health-facility contact reduce early infant mortality? Study protocol for a cluster-randomised trial (CS-BCG)
AU - Thysen, Sanne Marie
AU - Jensen, Andreas Moller
AU - Vedel, Julie Odgaard
AU - Borges, Igualdino da Silva
AU - Aaby, Peter
AU - Jensen, Aksel Karl Georg
AU - Benn, Christine Stabell
AU - Fisker, Ane Baerent
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - epidemiology
KW - public health
KW - tuberculosis
KW - community child health
KW - paediatric infectious disease & immunisation
KW - CALMETTE-GUERIN VACCINATION
KW - BIRTH-WEIGHT INFANTS
KW - GUINEA-BISSAU
KW - TUBERCULIN REACTION
KW - CHILD SURVIVAL
KW - SCAR
KW - STRAINS
U2 - 10.1136/bmjopen-2022-063872
DO - 10.1136/bmjopen-2022-063872
M3 - Journal article
C2 - 36410811
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - 063872
ER -