Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized Clinical Trial.

Objectives: Systemic fungal infections (SFIs) account for 12% of all late-onset sepsis among very low birth weight (VLBW) infants and result in adverse long-term neurodevelopmental outcomes among survivors. This study compared the prophylactic efficacies of systemic fluconazole or oral nystatin prophylaxis to prevent SFI in VLBW infants.

Methods: In a randomized controlled clinical trial, 120 neonates with gestational age < 32 weeks and birth weight < 1500 g were randomly allocated in two groups. Patients in group A received fluconazole 3 mg/kg intravenously twice weekly from the first 72 hours of life. Patients in group B were administered oral nystatin 1 mL (100 000 units) every eight hours. The primary endpoint was SFI and its associated mortality rate during hospital stay.

Results: The mean gestational age of the enrolled infants was 28.2±1.4 weeks. Demographic characteristics were similar in both groups. SFI was detected in six (5.0%) infants with three cases from each group. Three (2.5%) patients died, two of whom were in group B. Four (6.7%) patients in group B and one (1.7%) in group A were treated for retinopathy of prematurity (p = 0.040). Intraventricular hemorrhage was detected in brain ultrasound examination in three (5.0%) neonates in group B and seven (11.7%) in group A (p = 0.020).

Conclusions: The intravenous fluconazole and oral nystatin were similarly effective in preventing SFIs in VLBW infants. Future studies are recommended with a larger number of patients before routine administration of nystatin prophylaxis.