1. Randomized Trial of BCG Vaccination at Birth to Low-Birth-Weight Children: Beneficial Nonspecific Effects in the Neonatal Period?
- Author
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Karen Rokkedal Lausch, Birgitte Rode Diness, Hilton Whittle, Christine Stabell Benn, Bitiguida Mutna Napirna, Sofie Biering-Sørensen, Lone Graff Stensballe, Adam Roth, Amabelia Rodrigues, Ida Maria Lisse, Henrik Ravn, Peter Aaby, and Najaaraq Lund
- Subjects
Male ,Pediatrics ,medicine.medical_specialty ,Birth weight ,Population ,complex mixtures ,Infant Mortality ,medicine ,Humans ,Tuberculosis ,Immunology and Allergy ,Guinea-Bissau ,education ,education.field_of_study ,Neonatal sepsis ,business.industry ,Mortality rate ,Vaccination ,Infant, Newborn ,Respiratory infection ,Infant, Low Birth Weight ,medicine.disease ,Infant mortality ,Low birth weight ,Infectious Diseases ,BCG Vaccine ,Female ,medicine.symptom ,business ,BCG vaccine - Abstract
Background. Observational studies have suggested that BCG may have nonspecific beneficial effects on survival. Low-birth-weight (LBW) children are not given BCG at birth in Guinea-Bissau; we conducted a randomized trial of BCG at birth (early BCG) vs delayed BCG. Methods. In the period 2004-2008 we recruited 2320 LBW children in Bissau. The children were visited at home at 2, 6, and 12 months of age. With a pretrial infant mortality of 250 per 1000, we hypothesized a 25% reduction in infant mortality for LBW children. Results. Infant mortality was only 101 per 1000 during the trial. In the primary analysis, infant mortality was reduced insignificantly by 17% (mortality rate ratio [MRR] = .83 [.63-1.08]). In secondary analyses, early BCG vaccine was safe with an MRR of .49 (.21-1.15) after 3 days and .55 (.34-.89) after 4 weeks. The reduction in neonatal mortality was mainly due to fewer cases of neonatal sepsis, respiratory infection, and fever. The impact of early BCG on infant mortality was marked for children weighing
- Published
- 2011
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