Immediate Bacille Calmette-Guérin Vaccination to Neonates Requiring Perinatal Treatment at the Maternity Ward in Guinea-Bissau: A Randomized Controlled Trial.

Autor:	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
Předmět:	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
Zdroj:	Journal of Infectious Diseases; Dec2021, Vol. 224 Issue 11, p1935-1944, 10p
Abstrakt:	Background: 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%.Methods: 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).Results: 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).Conclusions: 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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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