| Author | Study design | Inclusion criteria | Drug/dose | Results | Conclusion/Comments |
| Kaufman et al. 2001 [5] | Prospective, randomized, double-blind clinical trial, 100 infants (50:50) (May 5, 1998, and October 10, 2000) | ELBW, Preterm neonates, and/or Central venous catheter, endotracheal intubation | IV fluconazole 3 mg/kg every third day for 2 weeks, then every other day for the third and fourth week, then daily during the fifth and sixth week vs. placebo (Schedule A) | Primary outcome: ColonizationΨ: Fungal colonization at one or more sites occurred in 30 of placebo group vs. 11 in the fluconazole group P 0.002
Infection developed in 10 in placebo group (20%) and none in fluconazole arm. (Risk difference: 0.20% P 0.008)
Secondary outcome: No difference in mortality between groups P 0.22 | Due to the concern of azole resistance fluconazole was limited to preterm infants who required central venous catheters and intubation during the six weeks of life
Author didn’t specify if additional risk factors are needed to be present in addition to ELBW, preterm and/or central venous catheter, endotracheal intubation **Candiuria was considered IC in this study**
**>Number of sites colonized >IC incidence** |
| Kaufman et al. 2005 [13] | Prospective, randomized, double-blind clinical trial, 82 infants (41:40)
| ELBW, Preterm, and/ or central venous catheter, endotracheal intubation | Regimen above (Schedule A) vs. Twice weekly (Schedule B) | Primary outcome: ColonizationΨ: Fungal colonization at one or more sites developed in 5 in group A vs. 4 in group B P 0.83
Infection: Two developed (Schedule A) IC vs. 1 in Schedule B. P value 0.68
Secondary outcome: No significant difference in mortality P 1.00 | Twice weekly fluconazole is as effective as conventional regimen. No adverse effects except reversible elevation in transaminases
Serum aminotransferrases were elevated in 2 of group A and in 4 of group B |
| Manzoni et al. 2007 [10] | Multicentre, prospective randomized, double-blind, placebo controlled trial, 322 infants (112 in 6 mg/kg group, 104 in 3 mg/kg group, 106 in placebo group) | VLBW, ELBW | IV fluconazole 3 mg/kg vs. 6 mg/kg vs. 1 ml NS every third day for 2 weeks, then every other day for the third and fourth week, then daily during the fifth and sixth week | Primary outcome: Colonization occurred less frequently in the 6-mg group 9.8% (11/112) and the 3-mg group 7.7% (8/104) than in the placebo group 29.2% (31/106) P < 0.001 for both comparisons.
IC occurred in 2.7% (3/112) of 6 mg/kg, 3.8% (4/104) of 3 mg/kg, and 13.2% (14/106) in placebo group P 0.005 and P value 0.02, respectively | Selection of fluconazole should be directed to high risk patients to minimize the overgrowth of fluconazole resistant candida strains.
Elevation in serum aminotransferases was reported in 4 neonates in fluconazole group and no elevation in placebo group P 0.31
**Candiduria was considered IC if >10,000 organisms/milliliter |