Background Candidal infection is a common cause of morbidity and mortality in neonatal intensive care unit (NICU) and pediatric intensive care unit(PICU) pateints, especially those with risk factors.

Objectives To determine the prevalence of Candida species in risky NICU and PICU patients and evaluate the efficacy of prophylactic Fluconazole in reducing Candida colonization and subsequent invasive candidemia in those patients.

Design Prospective, randomized, double blind placebo controlled clinical study.

Setting Tertiary level intensive care units at pediatric department.

Subjects 80 intensive care unit high risk group patient of neonatal and pediatric age.

Intervention Children were randomly grouped during first three days to receive either Fluconazole or placebo till 28 days or less, if discharged or died earlier. Weekly surveillance cultures from oropharyngeal swabs, urine, stool, sputum (when available), and blood.

Results Baseline risk factors for Candida infection in Fluconazole and Placebo groups were similar. Candida colonization was reported in 35 patients (87.5%) in the placebo group which was significantly higher (P =0.0001) than that detected among patients in the Fluconazole treated group [10 patients (25%)]. fluconazole treated group showed significantly lower colonization with Candida albicans (C. albicans) and higher colonization with non Candida albicans (non-C. albicans)versus placebo group. Invasive Candida infection was significantly higher (P=0.03) among placebo group than Fluconazole treated one. Invasive non-C. albicans infection was reported in 9/13 patients [6 patients (66.6%) in Placebo group and 3 patients (33.3%) in Fluconazole treated group].

Conclusion Prophylactic Fluconazole in risky patients in ICU is effective in reducing Candida colonization but not invasive candidemia.