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- Title
Immediate Bacille Calmette-Guérin Vaccination to Neonates Requiring Perinatal Treatment at the Maternity Ward in Guinea-Bissau: A Randomized Controlled Trial.
- Authors
Schaltz-Buchholzer, Frederik; Aaby, Peter; Monteiro, Ivan; Camala, Luis; Simonsen, Simone Faurholt; Frankel, Hannah Nørtoft; Larsen, Kristina Lindberg; Golding, Christian N; Kollmann, Tobias R; Amenyogbe, Nelly; Benn, Christine Stabell; Bjerregaard-Andersen, Morten; Faurholt Simonsen, Simone; Nørtoft Frankel, Hannah; Lindberg Larsen, Kristina; Stabell Benn, Christine
- Abstract
<bold>Background: </bold>Randomized controlled trials (RCTs) indicate that bacille Calmette-Guérin (BCG) vaccination provides broad beneficial "nonspecific" protection against infections. We investigated the effect on in-hospital mortality of providing BCG immediately upon admission to a neonatal intensive care unit (NICU), rather than BCG-at-discharge. The pretrial NICU mortality was 13% and we hypothesized that BCG would reduce mortality by 40%.<bold>Methods: </bold>Parallel-group, open-label RCT was initiated in 2013 in Guinea-Bissau. Neonatal intensive care unit-admitted neonates were randomized 1:1 to BCG + oral polio vaccine (OPV) immediately (intervention) versus BCG + OPV at hospital discharge (control; usual practice). The trial was discontinued due to decreasing in-hospital mortality and major NICU restructuring. We assessed overall and disease-specific mortality by randomization allocation in cox proportional hazards models providing mortality rate ratios (MRRs).<bold>Results: </bold>We recruited 3353 neonates, and the overall mortality was 3.1% (52 of 1676) for BCG-vaccinated neonates versus 3.3% (55 of 1677) for controls (MRR = 0.94; 0.64-1.36). For noninfectious causes of death, the MRR was 1.20 (0.70-2.07), and there tended to be fewer deaths from infections in the BCG group (N = 14) than among controls (N = 21) (MRR = 0.65; 0.33-1.28).<bold>Conclusions: </bold>Providing BCG + OPV to frail neonates was safe and might protect against fatal infection in the immediate newborn period. Deaths due to prematurity and perinatal complications were unaffected by BCG.
- Subjects
GUINEA-Bissau; NEONATAL intensive care units; HOSPITAL maternity services; RANDOMIZED controlled trials; NEWBORN infants; PROPORTIONAL hazards models; POLIO prevention; RESEARCH; COMMUNICABLE diseases; IMMUNIZATION; NEONATAL intensive care; RESEARCH methodology; EVALUATION research; HOSPITAL mortality; COMPARATIVE studies; BCG vaccines; SURVIVAL analysis (Biometry); RESEARCH funding; INFANT mortality
- Publication
Journal of Infectious Diseases, 2021, Vol 224, Issue 11, p1935
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jiab220