BCG vaccination to reduce early infant mortality
Can BCG Vaccination at First Health-facility Contact Reduce Early Infant Mortality? A Cluster Randomised Trial
This study is testing if giving the BCG vaccine right when babies first visit a health facility can help reduce early infant deaths in rural Guinea-Bissau.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 22800 (estimated) |
| Ages | 1 Day to 42 Days |
| Sex | All |
| Sponsor | Bandim Health Project Academic / other |
| Locations | 1 site (Bissau) |
| Trial ID | NCT04658680 on ClinicalTrials.gov |
What this trial studies
This study investigates whether administering the BCG vaccine at the first health facility contact can decrease early infant mortality rates in rural Guinea-Bissau. The trial will involve 23 health facilities that will be randomized to either continue their current vaccination practices or implement immediate BCG vaccination upon first contact. The hypothesis is that this approach could lead to a 25% reduction in early non-accidental infant mortality. The study aims to address the delays in BCG vaccination that are common in the region due to logistical challenges.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns registered during pregnancy in the specified health regions of Oio, Biombo, or Farim.
Not a fit: Patients who have died within one day after birth or those born outside the designated health regions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower early infant mortality rates in high-risk populations.
How similar studies have performed: Previous studies have shown promising results regarding the survival benefits of BCG vaccination in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All children registered during pregnancy in Oio, Biombo or Farim by CHWs or the BHP HDSS Exclusion Criteria: * Children, who have died within 1 day after birth * Children born outside Oio, Biombo and Farim health regions
Where this trial is running
Bissau
- Bandim Health Project — Bissau, Guinea-Bissau (Recruiting)
Study contacts
- Principal investigator: Ane B Fisker, MD, PhD — Bandim Health Project and University of Southern Denmark
- Study coordinator: Ane B Fisker, MD, PhD
- Email: afisker@health.sdu.dk
- Phone: +45 50570593/+245 956000403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.