Can earlier BCG-Japan and OPV vaccination reduce early infant mortality? A cluster-randomised trial in Guinea-Bissau.
BMJ Glob Health
; 9(2)2024 02 12.
Article
en En
| MEDLINE
| ID: mdl-38350670
ABSTRACT
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 11 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 OUTCOMEMEASURE:
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).Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Vacuna BCG
/
Mortalidad Infantil
Tipo de estudio:
Clinical_trials
Límite:
Child
/
Humans
/
Infant
/
Newborn
País/Región como asunto:
Africa
/
Asia
Idioma:
En
Revista:
BMJ Glob Health
Año:
2024
Tipo del documento:
Article
País de afiliación:
Guinea Bissau