Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau

ObjectiveTo assess the effect of providing BCG and oral polio vaccine (OPV) at an early home visit after delivery.DesignCluster-randomised trial, randomising 92 geographically defined clusters 1:1 to intervention/control arms.SettingBandim Health Project Health and Demographic Surveillance System, G...

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Published in:BMJ global health 2024-02, Vol.9 (2), p.e014044
Main Authors: Thysen, Sanne Marie, da Silva Borges, Igualdino, Martins, Jailson, Stjernholm, Alexander Dahl, Hansen, Jesper Sloth, da Silva, Leontino Manuel Vieira, Martins, Justiniano Sebastião Durga, Jensen, Aksel, Rodrigues, Amabelia, Aaby, Peter, Stabell Benn, Christine, Fisker, Ane Baerent
Format: Article
Language:English
Subjects:
Child mortality
Clinical trial
Consent
Epidemiology
Immunization
Infant mortality
Infants
Intervention
Nurses
Original Research
Poliomyelitis
Public Health
Rural areas
Tuberculosis
Umbilical cord
Urban areas
Vaccines
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Summary:ObjectiveTo assess the effect of providing BCG and oral polio vaccine (OPV) at an early home visit after delivery.DesignCluster-randomised trial, randomising 92 geographically defined clusters 1:1 to intervention/control arms.SettingBandim Health Project Health and Demographic Surveillance System, Guinea-Bissau.Participants2226 newborns enrolled between July 2016 and August 2019.InterventionsIn both arms, newborns received a home visit within 72 hours after birth. In intervention clusters (n=46), BCG and OPV were provided at the home visit.Main outcome measureRates of non-accidental mortality were compared in Cox proportional hazards models from (last of) day 1 or enrolment, until (first of) day 60 or registration of non-trial vaccines.ResultsA total of 35 deaths (intervention: 7, control: 28) were registered during the trial. Providing BCG and OPV reduced non-accidental early infant mortality by 59% (8–82%). The intervention also reduced non-accidental hospital admissions. The intervention had little impact on growth and BCG scarring and tended to increase the risk of consultations.ConclusionsThe trial was stopped early due to lower-than-expected enrolment and event rates when 33% of the planned number of newborns had been enrolled. Despite the small size of the trial, the results support that early BCG and OPV vaccinations are beneficial and reduce early child mortality and morbidity.Trial registration numberClinicalTrials.gov Registry (NCT02504203).
ISSN:2059-7908
2059-7908
DOI:10.1136/bmjgh-2023-014044