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.

Oman Medical Journal
|February 7, 2025
PubMed

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.
Abstract

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