Randomised controlled trial of prophylactic fluconazole versus nystatin for the prevention of fungal colonisation and invasive fungal infection in very low birth weight infants.
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.
Aydemir
Cumhur
C
Neonatal Intensive Care Unit, Zekai Tahir Burak Maternity Hospital, Samanpazari, Ankara, Turkey. chaydemir@hotmail.com
Oguz
Serife Suna
SS
Dizdar
Evrim Alyamac
EA
Akar
Melek
M
Sarikabadayi
Yusuf Unal
YU
Saygan
Sibel
S
Erdeve
Omer
O
Dilmen
Ugur
U
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
D000935:Antifungal Agents; D009761:Nystatin; D015725:Fluconazole