Autor: |
Sinha, Anju, Gupta, Subodh S., Chellani, Harish, Maliye, Chetna, Kumari, Vidya, Arya, Sugandha, Garg, B. S., Gaur, Sunita Dixit, Gaind, Rajni, Deotale, Vijayshri, Taywade, Manish, Prasad, M. S., Thavraj, Vasantha, Mukherjee, Ajit, Roy, Malabika |
Zdroj: |
BMJ Open; Jul2015, Vol. 5 Issue 7, p1-9, 9p |
Abstrakt: |
Objectives: To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants. Design: Randomised, double-blind, placebo-controlled trial. Setting: Community setting in rural India. Participants: LBW infants aged 3-7 days. Interventions: Infants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months. Main outcome measure: Possible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians. Results: 668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063). Conclusions: Daily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants. [ABSTRACT FROM AUTHOR] |
Databáze: |
Complementary Index |
Externí odkaz: |
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