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A Randomized Trial of Providing BCG Vaccination Immediately

Bandim Health Project · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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vaccines
Recent studies show that BCG vaccination reduces neonatal mortality by more than 40%. This effect cannot be explained by prevention of tuberculosis, which is very rare among infants. The protective effect of BCG vaccination is seen already within the first week. It seems that BCG provides a non-specific beneficial immune modulation - thereby reducing overall mortality. Mortality is very high among newborns admitted to the neonatal intensive care unit. If BCG has immediate beneficial effects on the immune system, vaccinating children with BCG as early as possible may save lives. The investigators will test this hypothesis in a randomized trial among newborns in Guinea-Bissau, randomizing newborns admitted to the neonatal intensive care unit at the National Hospital 1:1 to BCG immediately or at discharge (usual practice).
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