1. Rapid Protective Effects of Early BCG on Neonatal Mortality Among Low Birth Weight Boys: Observations From Randomized Trials.
- Author
-
Biering-Sørensen S, Jensen KJ, Monterio I, Ravn H, Aaby P, and Benn CS
- Subjects
- Age Factors, Female, Humans, Infant, Infant, Newborn, Male, Randomized Controlled Trials as Topic, Sex Factors, Treatment Outcome, BCG Vaccine administration & dosage, Infant Mortality, Infant, Low Birth Weight
- Abstract
Background: Three randomized trials (RCTs) in low-weight (<2.5 kg) infants have shown that Bacille Calmette-Guérin (BCG) vaccine nonspecifically reduces all-cause mortality in the neonatal period., Methods: Using data from 3 RCTs of early BCG (n = 6583) we examined potential sex differences in the timing of the mortality reduction in the neonatal period, presenting metaestimates of the main outcome mortality rate ratios (MRR) for BCG-vaccinated and controls., Results: Among controls, boys had a particularly high mortality during the first week after randomization: male-female MRR 2.71 (95% CI, 1.70-4.50). During the first week, BCG had a marked beneficial effect for boys, reducing mortality 3-fold (MRR [BCG/no BCG] = 0.36 [0.20-0.67]). In weeks 2-4 the effect waned for boys (MRR = 0.91 [0.51-1.69]). In girls, the pattern was opposite with a limited effect in the first week (MRR = 0.85 [0.46-1.54]), but a significant reduction in weeks 2-4 (MRR = 0.56 [0.31-1.00]). This was consistent in all 3 trials. Verbal autopsies linked early benefit to fewer sepsis-related deaths among BCG-vaccinated boys., Discussion: The marked reduction in mortality in the days after BCG vaccination in boys emphasizes the importance of providing BCG soon after birth., Trial Registration Numbers: ClinicalTrials.gov (NCT00146302) and ClinicalTrials.gov (NCT00625482)., (© The Author(s) 2017. Published by Oxford University Press for the Infectious Diseases Society of America.)
- Published
- 2018
- Full Text
- View/download PDF