title: Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial.
abstract: OBJECTIVE
  To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants.
  
  
  METHODS
  Randomised, double-blind, placebo-controlled trial.
  
  
  METHODS
  Community setting in rural India.
  
  
  METHODS
  LBW infants aged 3-7 days.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  The study is registered at the Clinical Trial Registry of India (CTRI/2008/091/000049).
authors.affiliation: Department of Reproductive and Child Health, Indian Council of Medical Research, New Delhi, Delhi, India.
authors.forename: Anju
authors.initials: A
authors.lastname: Sinha
authors.affiliation: Mahatma Gandhi Institute of Medical Sciences, Sewagram, Maharashtra, India.
authors.forename: Subodh S
authors.initials: SS
authors.lastname: Gupta
authors.affiliation: Safdarjung Hospital, New Delhi, Delhi, India.
authors.forename: Harish
authors.initials: H
authors.lastname: Chellani
authors.affiliation: Mahatma Gandhi Institute of Medical Sciences, Sewagram, Maharashtra, India.
authors.forename: Chetna
authors.initials: C
authors.lastname: Maliye
authors.affiliation: Safdarjung Hospital, New Delhi, Delhi, India.
authors.forename: Vidya
authors.initials: V
authors.lastname: Kumari
authors.affiliation: Safdarjung Hospital, New Delhi, Delhi, India.
authors.forename: Sugandha
authors.initials: S
authors.lastname: Arya
authors.affiliation: Mahatma Gandhi Institute of Medical Sciences, Sewagram, Maharashtra, India.
authors.forename: B S
authors.initials: BS
authors.lastname: Garg
authors.affiliation: District Hospital Wardha, Wardha, Maharashtra, India.
authors.forename: Sunita Dixit
authors.initials: SD
authors.lastname: Gaur
authors.affiliation: Safdarjung Hospital, New Delhi, Delhi, India.
authors.forename: Rajni
authors.initials: R
authors.lastname: Gaind
authors.affiliation: Mahatma Gandhi Institute of Medical Sciences, Sewagram, Maharashtra, India.
authors.forename: Vijayshri
authors.initials: V
authors.lastname: Deotale
authors.affiliation: Mahatma Gandhi Institute of Medical Sciences, Sewagram, Maharashtra, India.
authors.forename: Manish
authors.initials: M
authors.lastname: Taywade
authors.affiliation: Safdarjung Hospital, New Delhi, Delhi, India.
authors.forename: M S
authors.initials: MS
authors.lastname: Prasad
authors.affiliation: Department of Reproductive and Child Health, Indian Council of Medical Research, New Delhi, Delhi, India.
authors.forename: Vasantha
authors.initials: V
authors.lastname: Thavraj
authors.affiliation: Department of Reproductive and Child Health, Indian Council of Medical Research, New Delhi, Delhi, India.
authors.forename: Ajit
authors.initials: A
authors.lastname: Mukherjee
authors.affiliation: Department of Reproductive and Child Health, Indian Council of Medical Research, New Delhi, Delhi, India.
authors.forename: Malabika
authors.initials: M
authors.lastname: Roy
mesh_terms: D001424:Bacterial Infections / Q000453:epidemiology*; D004311:Double-Blind Method; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D007194:India; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D053208:Kaplan-Meier Estimate; D008297:Male; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects / Q000145:classification; D018805:Sepsis / Q000517:prevention & control*; D016896:Treatment Outcome
keywords: NEONATOLOGY