title: Randomised controlled trial of prophylactic fluconazole versus nystatin for the prevention of fungal colonisation and invasive fungal infection in very low birth weight infants.
abstract: BACKGROUND
  Invasive fungal infections are a major cause of morbidity and mortality in preterm infants. The authors conducted the first prospective, randomised controlled trial of nystatin compared with fluconazole for the prevention of fungal colonisation and invasive fungal infection in very low birth weight (VLBW) neonates.
  
  
  METHODS
  During a 12-month period, all VLBW neonates were assigned randomly to receive nystatin (1 ml suspension, 100 000 U/ml, every 8 h), fluconazole (3 mg/kg body weight, every third day) or placebo from birth until day 30 of life (day 45 for neonates weighing <1000 g at birth). The authors performed weekly surveillance cultures and systemic fungal susceptibility testing.
  
  
  RESULTS
  During the study period, 278 infants (fluconazole group, n=93; nystatin group, n=94; control group, n=91) weighing <1500 g at birth were admitted. There were no differences in birth weight, gestation, gender or risk factors for fungal infection among the groups. Fungal colonisation occurred in 11.7% of the nystatin group and 10.8% of the fluconazole group, as compared with 42.9% of the control group. The incidence of invasive fungal infection was 4.3% in the nystatin group and 3.2% in the fluconazole group, as compared with 16.5% in the control group. There were no differences in fungal colonisation and invasive fungal infection between the nystatin and fluconazole groups.
  
  
  CONCLUSIONS
  Prophylactic nystatin and fluconazole reduce the incidence of colonisation and invasive fungal infection in VLBW neonates. The authors believe that nystatin is an alternative to fluconazole, because nystatin is safe, inexpensive, well tolerated and effective.
authors.affiliation: Neonatal Intensive Care Unit, Zekai Tahir Burak Maternity Hospital, Samanpazari, Ankara, Turkey. chaydemir@hotmail.com
authors.forename: Cumhur
authors.initials: C
authors.lastname: Aydemir
authors.forename: Serife Suna
authors.initials: SS
authors.lastname: Oguz
authors.forename: Evrim Alyamac
authors.initials: EA
authors.lastname: Dizdar
authors.forename: Melek
authors.initials: M
authors.lastname: Akar
authors.forename: Yusuf Unal
authors.initials: YU
authors.lastname: Sarikabadayi
authors.forename: Sibel
authors.initials: S
authors.lastname: Saygan
authors.forename: Omer
authors.initials: O
authors.lastname: Erdeve
authors.forename: Ugur
authors.initials: U
authors.lastname: Dilmen
mesh_terms: D000935:Antifungal Agents / Q000627:therapeutic use*; D001724:Birth Weight; D018450:Disease Progression; D025141:Drug Resistance, Fungal; D004812:Epidemiologic Methods; D005260:Female; D015725:Fluconazole / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000517:prevention & control*; D019102:Infant, Very Low Birth Weight; D008297:Male; D008826:Microbial Sensitivity Tests / Q000379:methods; D009181:Mycoses / Q000517:prevention & control*; D009761:Nystatin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D009761:Nystatin; D015725:Fluconazole