TY - JOUR
T1 - Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau
AU - Thysen, Sanne Marie
AU - da Silva Borges, Igualdino
AU - Martins, Jailson
AU - Stjernholm, Alexander Dahl
AU - Hansen, Jesper Sloth
AU - da Silva, Leontino Manuel Vieira
AU - Martins, Justiniano Sebastião Durga
AU - Jensen, Aksel
AU - Rodrigues, Amabelia
AU - Aaby, Peter
AU - Benn, Christine Stabell
AU - Fisker, Ane Baerent
PY - 2024/2/12
Y1 - 2024/2/12
N2 - Objective To assess the effect of providing BCG and oral polio vaccine (OPV) at an early home visit after delivery. Design Cluster-randomised trial, randomising 92 geographically defined clusters 1:1 to intervention/control arms. Setting Bandim Health Project Health and Demographic Surveillance System, Guinea-Bissau. Participants 2226 newborns enrolled between July 2016 and August 2019. Interventions In 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 measure Rates 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. Results A 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. Conclusions The 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 number ClinicalTrials.gov Registry (NCT02504203).
AB - Objective To assess the effect of providing BCG and oral polio vaccine (OPV) at an early home visit after delivery. Design Cluster-randomised trial, randomising 92 geographically defined clusters 1:1 to intervention/control arms. Setting Bandim Health Project Health and Demographic Surveillance System, Guinea-Bissau. Participants 2226 newborns enrolled between July 2016 and August 2019. Interventions In 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 measure Rates 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. Results A 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. Conclusions The 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 number ClinicalTrials.gov Registry (NCT02504203).
U2 - 10.1136/bmjgh-2023-014044
DO - 10.1136/bmjgh-2023-014044
M3 - Journal article
C2 - 38350670
AN - SCOPUS:85185886791
SN - 2059-7908
VL - 9
JO - BMJ Global Health
JF - BMJ Global Health
IS - 2
M1 - e014044
ER -