Prophylactic fluconazole in very low birth weight infants admitted to neonatal intensive care unit: randomized controlled trial

Abstract

Objective: To evaluate the effect of fluconazole prophylaxis on invasive fungal infection (IFI) in very low birth weight (VLBW) infants in the Neonatal Intensive Care Unit (NICU).

Methods: VLBW infants receiving antibiotics for more than 3 days were randomized to receive either fluconazole (6 mg/kg) or placebo, every other day for 7 days followed by everyday till day 28 or discharge whichever was earlier. The primary outcome was IFI, and secondary outcome was fungal attributable mortality and all-cause mortality.

Results: The incidence of IFI was significantly lower (21%) in the fluconazole group compared to the control group (43.2%, 95%CI 0.09–0.37, p < 0.05). The ARR (absolute risk reduction) was 22.2% and the NNT (number needed to treat) was 5. Fungal attributable mortality was also lower in the fluconazole group (2.6% versus 18.9%, 95%CI 0.003–0.52, p < 0.05).

Conclusion: In VLBW neonates on the NICU, use of fluconazole prophylaxis decreases IFI and fungal attributable mortality.

Keywords:

• Fungal sepsis
• prophylactic fluconazole
• VLBW infants

Declaration of interest

The authors have no conflicts of interest relevant to this article to disclose. No external funding was secured for this study. The authors have no financial relationships relevant to this article to disclose.