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Probiotics for prevention of suspected sepsis in low birthweight infants

Low birthweight (LBW) is an important indirect cause of neonatal mortality and infections. Considering nearly 30% prevalence of LBW in India and nearly one-third of these neonates dying due to sepsis, even a modest decline in the incidence of sepsis due to a preventive intervention could potentially avert thousands of neonatal deaths (1). Amongst the immunotherapeutic agents for sepsis prevention, probiotics have attracted both interest and debate in the past decade (2,3) with many institutions using probiotics routinely (4). A review of the level of evidence for probiotics in preterm infants suggests no side effects and long-term outcomes are reassuring (5). The concept of probiotics being helpful in prevention of sepsis seems interesting and novel because few interventions have been proven to be effective in preventing sepsis in LBW infants, apart from exclusive breastfeeding and hand hygiene (6,7). This study aimed to estimate reduction in incidence of suspected sepsis in zeroto twomonth-old LBW infants with a daily supplementation of probiotic VSL#3 (10 billion colony-forming units over a period of 30 days). This intervention, if proven to be efficacious, could be an important public health intervention for prevention of neonatal infections. The study showed no significant reduction in the risk of suspected sepsis (PSBI) diagnosed by the fieldworker. In the un-pre-specified subgroup (weighing 1500–1999 g), the reduction in risk of PSBI was statistically significant. This study was a community-based randomised trial from with high rates of follow-up and good adherence to treatment in both groups. There are, however, a few important limitations which need to be considered before presuming a possible beneficial role of probiotic administration in LBWinfants for prevention of sepsis. First, the findings of statistically significant reduction in PSBI in the subgroup weighing 1500–1999 g might be a chance finding because of the small numbers involved. Second, suspected sepsis in itself is not an objective outcome. The significant difference in the subgroup analysis makes it imperative to interpret the results with caution. Third, there was no statistical difference in the colony counts in the two groups on days 1, 21 and 60. The authors mention the absence of an interaction effect between the treatment and the birthweight group which is not clear. Fourth, the intervention initiated on days 3–7 cannot address the risk of early-onset sepsis (EOS), an important cause of morbidity and mortality in LBW neonates. Hence, it may be incorrect to interpret this modest decline in the incidence of sepsis being attributed to due to preventive intervention with probiotics. To conclude, this study suggests possible modest beneficial effect in the subgroup of infants weighing 1500–1999 g. The results underscore the need of a larger study with sufficient power to conclusively evaluate the role of probiotics amongst LBW infants in a population at high risk of mortality from sepsis. Assuming the overall mortality in low birthweight infants to be 20% and the addition of probiotics shall decrease this rate by an absolute value 5% (to 15%); nearly 945 infants will be required in each group (assuming study power to be 80%).