Effect of BCG Danish and oral polio vaccine on neonatal mortality in newborn babies weighing less than 2000 g in India: multicentre open label randomised controlled trial (BLOW2).

ABSTRACT:

Objective

To test the effect on all cause neonatal mortality (aged ≤28 days) of a dose of BCG Danish vaccine and oral polio vaccine (OPV) administered to newborn babies weighing <2000 g.

Design

Multicentre, open label, randomised controlled trial SETTING: Three tertiary neonatal intensive care units (NICUs) in southeast India.

Population

Newborn babies weighing <2000 g. 7067 were assessed for eligibility and 5420 were randomised (2714 BCG-OPV, 2706 control).

Interventions

Newborns were randomised 1:1 to receive 0.1 mL of BCG Danish intradermally plus OPV, either within 48 hours of admission to the NICU (early vaccination group) or delayed until at least the time of discharge (control group). Stratification was by NICU, sex, and birth weight (<1000 g, 1000-1499

SUBMITTER: Adhisivam B 

PROVIDER: S-EPMC12452093 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature