title: Neutral and acidic oligosaccharides in preterm infants: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Serious infectious morbidity is high in preterm infants. Enteral supplementation of prebiotics may reduce the incidence of serious infections, especially infections related to the gastrointestinal tract.
  
  
  OBJECTIVE
  The objective was to determine the effect of enteral supplementation of a prebiotic mixture consisting of neutral oligosaccharides ((SC)GOS/(LC)FOS) and acidic oligosaccharides (AOS) on serious infectious morbidity in preterm infants.
  
  
  METHODS
  In a randomized controlled trial, preterm infants (gestational age <32 wk and/or birth weight <1500 g) received enteral supplementation of 80% (SC)GOS/(LC)FOS and 20% AOS (1.5 g . kg(-1) . d(-1)) or placebo (maltodextrin) between days 3 and 30 of life. Serious infectious morbidity was defined as a culture positive for sepsis, meningitis, pyelonephritis, or pneumonia. The analysis was performed by intention-to-treat and per-protocol, defined as > or =50% supplementation dose during the study period.
  
  
  RESULTS
  In total, 113 preterm infants were included. Baseline and nutritional characteristics were not different between groups. In the intention-to-treat analysis, the incidence of > or =1 serious infection, > or =1 serious endogenous infection, or > or =2 serious infectious episodes was not significantly different in the (SC)GOS/(LC)FOS/AOS-supplemented and placebo groups. In the per-protocol analysis, there was a trend toward a lower incidence of > or =1 serious endogenous infection and > or =2 serious infectious episodes in the (SC)GOS/(LC)FOS/AOS-supplemented group than in the placebo group (P = 0.09 and P = 0.07, respectively).
  
  
  CONCLUSIONS
  Enteral supplementation of (SC)GOS/(LC)FOS/AOS does not significantly reduce the risk of serious infectious morbidity in preterm infants. However, there was a trend toward a lower incidence of serious infectious morbidity, especially for infections with endogenous bacteria. This finding suggests a possible beneficial effect that should be evaluated in a larger study. This trial was registered at isrctn.org as ISRCTN16211826.
authors.affiliation: Department of Pediatrics, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Elisabeth Am
authors.initials: EA
authors.lastname: Westerbeek
authors.forename: Jolice P
authors.initials: JP
authors.lastname: van den Berg
authors.forename: Harrie N
authors.initials: HN
authors.lastname: Lafeber
authors.forename: Willem Pf
authors.initials: WP
authors.lastname: Fetter
authors.forename: Guenther
authors.initials: G
authors.lastname: Boehm
authors.forename: Jos Wr
authors.initials: JW
authors.lastname: Twisk
authors.forename: Ruurd M
authors.initials: RM
authors.lastname: van Elburg
mesh_terms: D000143:Acids; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D003141:Communicable Diseases / Q000453:epidemiology*; D003428:Cross Infection / Q000453:epidemiology / Q000517:prevention & control*; D019587:Dietary Supplements; D004311:Double-Blind Method; D004750:Enteral Nutrition / Q000379:methods; D005260:Female; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000382:microbiology / Q000517:prevention & control*; D057194:Intention to Treat Analysis; D008297:Male; D008581:Meningitis / Q000453:epidemiology / Q000517:prevention & control; D009844:Oligosaccharides / Q000627:therapeutic use*; D011014:Pneumonia / Q000453:epidemiology / Q000517:prevention & control; D056692:Prebiotics; D011704:Pyelonephritis / Q000453:epidemiology / Q000517:prevention & control; D012306:Risk; D018805:Sepsis / Q000453:epidemiology / Q000517:prevention & control
chemical_list: D000143:Acids; D000890:Anti-Infective Agents; D009844:Oligosaccharides; D056692:Prebiotics