Twenty-two studies (more than 10,000 neonatal intensive care unit patients, range 13 to 719) were included in the review.
All seven studies that evaluated the impact of antifungal prophylaxis with fluconazole on Candida colonisation demonstrated a reduction in incidence of fungal colonisation. Twelve out of 16 studies that evaluated the impact of fluconazole prophylaxis on the incidence of invasive fungal infection demonstrated a reduction in invasive fungal infection.
All three studies that evaluated the impact of antifungal prophylaxis with nystatin on Candida colonisation and/or invasive fungal infection demonstrated a reduction in colonisation/invasive infection in the nystatin group.
Two randomised controlled trials found no statistically significant difference between fluconazole and nystatin in terms of invasive fungal infection and/or fungal colonisation.
In one study there were more deaths in the nystatin group than in the fluconazole group. Although none of the deaths were associated with an invasive fungal infection they may have been linked to nystatin use. Six studies reported that no adverse reactions to fluconazole were observed. One study reported that no hepatotoxicity associated with fluconazole use was observed. One study reported a higher incidence of conjugated hyperbilirubinaemia in the fluconazole group than the control group and one study reported a higher incidence of direct hyperbilirubinaemia and elevated liver transaminases in the control group than the fluconazole group.