Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial
Launched by BANDIM HEALTH PROJECT · Jul 20, 2015
Trial Information
Current as of June 28, 2025
Terminated
Keywords
ClinConnect Summary
Background: BCG and oral polio vaccines (OPV) at birth are associated with beneficial non-specific effects, reducing neonatal mortality by more than what can be explained by prevention of the target diseases. BCG is recommended at birth, but is often given much later, especially in rural areas. In two RCTs in Guinea-Bissau, BCG-at-birth reduced neonatal mortality in low birthweight (\<2500g; LBW) children by 48% (95%CI: 18-67%) and in children with a birthweight \>2500g (NBW), OPV+BCG vs BCG was associated with a 32% (95%CI: 0-55%) lower mortality.
WHO recommends home visits shortly after ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • • All children registered during pregnancy will be eligible for the study provided they have not yet received BCG at the date of the home visit.
- Exclusion Criteria:
- • Children born outside the cluster, and returning more than 72 hours after the delivery
- • Children that the nurse evaluates to die within the next 24 hours.
About Bandim Health Project
The Bandim Health Project is a leading research initiative based in Guinea-Bissau, dedicated to improving public health outcomes through rigorous scientific investigation. Established in collaboration with local health authorities and international partners, the project focuses on a wide range of health issues, including disease prevention, maternal and child health, and infectious diseases. With a commitment to evidence-based practices, the Bandim Health Project conducts clinical trials and observational studies to inform healthcare policies and interventions, ultimately aiming to enhance health services and promote well-being in the region. Through its innovative research and community engagement, the project plays a crucial role in advancing global health knowledge and practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bissau, , Guinea Bissau
Patients applied
Trial Officials
Sanne M Thysen, MD, PhD
Principal Investigator
Bandim Health Project
Ane B Fisker, MD,PhD
Principal Investigator
Bandim Health Project
Amabelia Rodrigues, PhD
Principal Investigator
Bandim Health Project
Christine S Benn, MD,PhD,DMSc
Study Director
Research Center for Vitamins and Vaccines
Peter Aaby, PhD,DMSc
Study Director
Bandim Health Project
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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