Probiotics in Prevention of Suspected Sepsis in Low Birth Weight Infants in India: A Randomized Controlled Trial
Low birth weight (LBW) neonates have a high predisposition for infections such as neonatal sepsis which is associated with high mortality, adverse neurological outcomes and poor growth. Probiotics have been effective in preventing neonatal necrotising enterocolitis and nosocomial infections. Their role in preventing neonatal sepsis is inconclusive. We conducted a multicentre randomised, double-blind, placebo-controlled trial involving infants weighing 1500-2500 g to evaluate the efficacy of the probiotic VSl#3 in preventing neonatal sepsis.
METHODS:
Eligible infants were randomly assigned at 3 days of age to receive either daily oral probiotic (#VSL3) or placebo for 30 days, and followed up in the community for two months. The primary outcome was possible serious bacterial infection (PSBI) as per Integrated Management of Neonatal Childhood Illnesses algorithm, diagnosed by field workers/physicians.
RESULTS:
In the probiotic group the risk of PSBI among infants with birth weights 1.5-1.99 kgwas significantly reduced (RR 0.29 [95% CI 0.10, 0.84]) and there was a non-significant 21% reduction in the overall risk of PSBI(RR 0.79 [95% CI 0.56]1.03) in intention-to-treat analysis. Probiotic reduced hospitalization rate (29 infants vs 44 in the placebo arm [p=0.038]) and mean days of hospitalization (4.6 ± 4.4 vs 6.9 ± 5.6 in the placebo arm[p=<0.0001]). Kaplan-Meier analysis showed the onset PSBI in 10 % of study subjects occurred on the 40th day in the probiotic arm and the25th day in the control arm (p=0.063).
CONCLUSIONS:
There was a significant reduction in PSBI rates in the probiotic group among infants weighing 1.5-1.99 kg. There is a need to conduct a study with larger sample size and confirmed neonatal sepsis as the primary outcome measure.