Document Type : Original Article
Authors
1
Student Research Committee, School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
2
Mother and Newborn Health Research Center, Comprehensive Research institute for Maternal and Child Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
3
Children Growth Disorder Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
4
Department of Biostatistics and Epidemiology, Center for Healthcare Data Modeling, Shahid Sadoughi University of Medical Sciences, Yazd
5
University of Medicine and Pharmacy "Grigore T. Popa", Lasi, Romania
Abstract
Background: Invasive fungal infections (IFIs) cause significant morbidity and mortality in very-low-birth-weight (VLBW) infants, but the benefit of routine fluconazole prophylaxis in units with low baseline IFI rates is unclear. We evaluated the efficacy and safety of intravenous fluconazole prophylaxis on clinical outcomes of VLBW infants.
Methods: In this randomized, open-label, controlled trial, 80 infants with birth weight <1500 g and gestational age ≥25 weeks admitted to a NICU in Yazd, Iran, were randomly assigned to intravenous fluconazole (3 mg/kg twice weekly for 4 weeks; n=40) or standard care (n=40). The primary outcome was IFI (positive blood culture at week 4). Secondary outcomes included respiratory, gastrointestinal, neurological, hematological, and mortality outcomes.
Results: IFI occurred in one infant (2.5%) in the fluconazole group versus none in controls (P=1.000); the overall prevalence was 1.25%. In unadjusted comparisons, fluconazole was associated with higher bronchopulmonary dysplasia (40% vs. 17.5%, P=0.047), apnea (45% vs. 20%, P=0.031), necrotizing enterocolitis (40% vs. 17.5%, P=0.047), longer respiratory support (28.18 vs. 19.72 days, P=0.047), and third-week neutropenia (15% vs. 0%, P=0.026). However, fluconazole infants had lower gestational age (29.1 vs. 30.6 weeks; P=0.0036) and birth weight (1082 vs. 1222 g; P=0.0035). Mortality, intraventricular hemorrhage, retinopathy of prematurity, and length of stay did not differ. No hepatotoxicity occurred.
Conclusion: In a NICU with low IFI prevalence (≤2%), routine fluconazole prophylaxis did not reduce infection. The unadjusted excess morbidity was confounded by baseline differences in gestational age and birth weight. These findings do not support routine prophylaxis in similar low-endemicity settings.
Keywords
Journal of Integrated Maternal and Pediatric Care