title: Bovine lactoferrin prevents invasive fungal infections in very low birth weight infants: a randomized controlled trial.
abstract: BACKGROUND
  Lactoferrin is a mammalian milk glycoprotein involved in innate immunity. Recent data show that bovine lactoferrin (bLF) prevents late-onset sepsis in preterm very low birth weight (VLBW) neonates.
  
  
  METHODS
  This is a secondary analysis of data from a multicenter randomized controlled trial where preterm VLBW neonates randomly received bLF (100 mg/day; group A1), bLF + Lactobacillus rhamnosus GG (10(6) colony-forming units per day; group A2), or placebo (group B) for 6 weeks. Here we analyze the incidence rates of fungal colonization, invasive fungal infection (IFI), and rate of progression from colonization to infection in all groups.
  
  
  RESULTS
  This study included 472 neonates whose clinical, nutritional, and demographical characteristics were similar. Overall, the incidence of fungal colonization was comparable (17.6%, 16.6%, and 18.5% in A1, A2, and B, respectively; P = .89 [A1] and .77 [A2]). In contrast, IFIs were significantly decreased in A1 and A2 (0.7% and 2.0%, respectively) compared with B (7.7%; P = .002 [A1] and .02 [A2]), and this was significantly true both in <1000 g (0.9% [A1] and 5.6% [A2], vs 15.0%) and in 1001 to 1500 g infants (0% and 0% vs 3.7%). The progression rate colonization-infection was significantly lower in the bLF groups: 3.7% (A1) and 12% (A2), vs 41.9%; P < .001 (A1) and P = .02 (A2). No IFI-attributable deaths occurred in the treatment groups, versus 2 in placebo. No adverse effects or intolerances occurred.
  
  
  CONCLUSIONS
  Prophylactic oral administration of bLF reduces the incidence of IFI in preterm VLBW neonates. No effect is seen on colonization. The protective effect on IFI is likely due to limitation of ability of fungal colonies to progress toward invasion and systemic disease in colonized infants.
authors.affiliation: Department of Neonatology and NICU, S. Anna Hospital, Azienda Ospedaliera Regina Margherita-S. Anna, C. Spezia 60, 10126 Torino, Italy. paolomanzoni@hotmail.com
authors.forename: Paolo
authors.initials: P
authors.lastname: Manzoni
authors.forename: Ilaria
authors.initials: I
authors.lastname: Stolfi
authors.forename: Hubert
authors.initials: H
authors.lastname: Messner
authors.forename: Silvia
authors.initials: S
authors.lastname: Cattani
authors.forename: Nicola
authors.initials: N
authors.lastname: Laforgia
authors.forename: Mario G
authors.initials: MG
authors.lastname: Romeo
authors.forename: Lina
authors.initials: L
authors.lastname: Bollani
authors.forename: Matteo
authors.initials: M
authors.lastname: Rinaldi
authors.forename: Elena
authors.initials: E
authors.lastname: Gallo
authors.forename: Michele
authors.initials: M
authors.lastname: Quercia
authors.forename: Milena
authors.initials: M
authors.lastname: Maule
authors.forename: Michael
authors.initials: M
authors.lastname: Mostert
authors.forename: Lidia
authors.initials: L
authors.lastname: Decembrino
authors.forename: Rosario
authors.initials: R
authors.lastname: Magaldi
authors.forename: Fabio
authors.initials: F
authors.lastname: Mosca
authors.forename: Federica
authors.initials: F
authors.lastname: Vagnarelli
authors.forename: Luigi
authors.initials: L
authors.lastname: Memo
authors.forename: Pasqua M
authors.initials: PM
authors.lastname: Betta
authors.forename: Mauro
authors.initials: M
authors.lastname: Stronati
authors.forename: Daniele
authors.initials: D
authors.lastname: Farina
mesh_terms: D000818:Animals; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002417:Cattle; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000517:prevention & control*; D019102:Infant, Very Low Birth Weight; D007781:Lactoferrin / Q000627:therapeutic use*; D009181:Mycoses / Q000517:prevention & control*; D019936:Probiotics / Q000008:administration & dosage
chemical_list: D000890:Anti-Infective Agents; D007781:Lactoferrin