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Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized
Leila Asgarzadeh1, Majid Mahallei1, Manizheh Mostafa Gharehbaghi1
1Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Insights
Systemic fluconazole and oral nystatin equally prevent fungal infections in very low birth weight infants. Further research is needed before widespread nystatin use.
Area of Science:
- Neonatal Medicine
- Infectious Diseases
- Pharmacology
Background:
- Systemic fungal infections (SFIs) are a significant concern in very low birth weight (VLBW) infants, contributing to 12% of late-onset sepsis.
- SFIs in VLBW infants are associated with poor neurodevelopmental outcomes in survivors.
Purpose of the Study:
- To compare the prophylactic efficacy of systemic fluconazole versus oral nystatin in preventing SFIs in VLBW infants.
Main Methods:
- A randomized controlled trial involving 120 neonates with gestational age < 32 weeks and birth weight < 1500 g.
- Group A received intravenous fluconazole (3 mg/kg twice weekly); Group B received oral nystatin (100,000 units every 8 hours).
- Primary endpoint: incidence of SFI and associated mortality during hospitalization.
Main Results:
- SFIs occurred in 5.0% of infants (3 in each group).
- Mortality was 2.5% (3 deaths), with two deaths in the nystatin group.
- Retinopathy of prematurity was more frequent in the nystatin group (6.7% vs 1.7%).
- Intraventricular hemorrhage was more frequent in the nystatin group (5.0% vs 11.7%).
Conclusions:
- Intravenous fluconazole and oral nystatin demonstrated similar effectiveness in preventing SFIs in VLBW infants.
- Larger studies are recommended to evaluate routine nystatin prophylaxis.
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.
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