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Prophylactic fluconazole in very low birth weight infants admitted to neonatal intensive care unit: randomized
Harita Kirpal1, Geeta Gathwala1, Uma Chaudhary2
1a Department of Paediatrics .
Insights
Fluconazole prophylaxis significantly reduced invasive fungal infections (IFI) and fungal-related deaths in very low birth weight (VLBW) infants. This treatment is crucial for improving outcomes in Neonatal Intensive Care Units (NICUs).
Area of Science:
- Neonatal Medicine
- Infectious Diseases
- Pharmacology
Background:
- Invasive fungal infections (IFI) pose a significant threat to very low birth weight (VLBW) infants in Neonatal Intensive Care Units (NICUs).
- Prophylactic antifungal agents are considered to reduce the incidence of IFI in this vulnerable population.
Purpose of the Study:
- To investigate the efficacy of fluconazole prophylaxis in preventing IFI among VLBW infants.
- To assess the impact of fluconazole on fungal-attributable mortality and overall mortality.
Main Methods:
- A randomized controlled trial was conducted involving VLBW infants receiving antibiotics for over 3 days.
- Participants were assigned to receive either fluconazole or a placebo, with treatment administered for up to 28 days.
- Primary endpoint was the incidence of IFI, with secondary endpoints including fungal-attributable and all-cause mortality.
Main Results:
- The incidence of IFI was substantially lower in the fluconazole group (21%) compared to the placebo group (43.2%).
- Fluconazole prophylaxis resulted in a significant reduction in fungal-attributable mortality (2.6% vs. 18.9%).
- The absolute risk reduction for IFI was 22.2%, with a number needed to treat of 5.
Conclusions:
- Fluconazole prophylaxis is effective in decreasing the incidence of IFI in VLBW neonates.
- The use of fluconazole significantly lowers fungal-attributable mortality in this high-risk group.
- Prophylactic fluconazole should be considered for VLBW infants in the NICU to reduce fungal-related complications.
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.
