Reducing neonatal mortality through administration of BCG soon after birth - a cluster randomised trial of improved service delivery

Rationale: Newborns are vulnerable and have high mortality in low income countries. BCG vaccine is known to stimulate the immune system and its early administration can modulate how the child copes with other infections. In randomised trials of BCG-at-birth to low-birth-weight (LBW) children, we have shown that BCG is associated with 40-50% lower neonatal mortality, the effect being due to less neonatal sepsis and respiratory infections. The beneficial effect has been observed already within the first three days.

Approach: In a cluster randomised trial of improved service delivery, neonatal mortality will be compared in intervention villages, where BCG will be administered at home as soon as possible after birth, to control villages, where BCG is only available through contact with the nearest health centre or at one-monthly outreach by a vaccination team. Community collaborators, mobile phones and mobile nurses will be used.

Objective and impact: To show that improved service for BCG vaccination reduces early neonatal mortality by at least 50% in the intervention villages compared with control villages where vaccines are only provided once a month through routine services. If true, many lives may be saved in high-mortality countries at a very low cost.

Innovation: BCG vaccine, which is used only to prevent tuberculosis (TB), will be applied in a new manner so that it may have an impact on early neonatal mortality. It is new to use BCG's immuno-enhancing effects to prevent non-TB deaths among newborns.