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Updated: Jul 7, 2026
06:27
Transcutaneous Microcirculatory Imaging in Preterm Neonates
Published on: December 31, 2015
A multicenter, randomized trial of prophylactic fluconazole in preterm neonates
Paolo Manzoni1, Ilaria Stolfi, Lorenza Pugni
1Neonatology and Hospital Neonatal Intensive Care Unit, Sant'Anna Hospital, Turin, Italy. paolomanzoni@hotmail.com
The New England Journal of Medicine
|June 15, 2007
Summary
Prophylactic fluconazole significantly reduced fungal colonization and invasive Candida infections in very-low-birth-weight neonates. This study highlights fluconazole
Area of Science:
- Neonatal Medicine
- Infectious Diseases
- Pharmacology
Background:
- Invasive Candida infections pose significant risks to preterm infants, contributing to morbidity and mortality.
- Very-low-birth-weight neonates are particularly vulnerable to fungal infections.
Purpose of the Study:
- To evaluate the efficacy of fluconazole in preventing fungal colonization and invasive infections in neonates weighing less than 1500 g.
- To assess the impact of prophylactic fluconazole on key neonatal health outcomes.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial involving 322 very-low-birth-weight neonates.
- Administration of fluconazole (3 mg or 6 mg/kg) or placebo from birth to day 30/45.
- Weekly surveillance cultures and fungal susceptibility testing were conducted.
Main Results:
- Fluconazole significantly reduced fungal colonization (7.7-9.8%) compared to placebo (29.2%).
- Invasive fungal infections decreased significantly with fluconazole (2.7-3.8%) versus placebo (13.2%).
- No significant differences in mortality or cholestasis were observed; no resistant Candida strains emerged.
Conclusions:
- Prophylactic fluconazole is effective in reducing Candida colonization and invasive infections in high-risk neonates.
- The clinical benefit of treating established Candida colonization requires further investigation.
- The study provides evidence for fluconazole's role in neonatal intensive care units.
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