Biering–Sørensen S, et al. – The experts aimed to figure out whether early Bacille Calmette–Guérin (BCG)–Denmark reduces neonatal mortality by 45%. Their findings approved that early administration of BCG–Denmark in low–weight (LW) infants was associated with major reductions in mortality rate. They suggested that it was important that all LW infants receive early BCG in areas with high neonatal mortality rates.

Methods

• LW neonates were randomized to “early BCG–Denmark” (intervention group; n = 2083) or “control” (local policy for LW and no BCG–Denmark; n = 2089) at discharge from the maternity ward or at first contact with the health center, in 2008–2013.
• The infants were randomized (1:1) without blinding in blocks of 24.
• In Cox hazards models, data was evaluated and mortality rate ratios (MRRs).
• The experts prespecified an analysis censoring follow–up at oral poliovirus vaccine campaigns.

Results

• Findings revealed that early administration of BCG–Denmark was associated with a nonsignificant reduction in neonatal mortality rate (MRR, 0.70; 95% confidence interval [CI], .47–1.04) and a 34% reduction (0.66; .44–1.00) when censoring for oral poliovirus vaccine campaigns.
• No reduction in mortality rate for noninfectious diseases was observed.
• However, a 43% reduction in infectious disease mortality rate was reported (MRR, 0.57; 95% CI, .35–.93).
• A meta–analysis of 3 BCG trials displayed that early BCG–Denmark reduced mortality by 38% (MRR, 0.62; 95% CI, .46–.83) within the neonatal period and 16% (0.84; .71–1.00) by age 12 months.