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 prop...

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Main Authors: Leila Asgarzadeh, Majid Mahallei, Manizheh Mostafa Gharehbaghi
Format: Article
Language:English
Published: Oman Medical Specialty Board 2024-07-01
Series:Oman Medical Journal
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Online Access:https://omjournal.org/articleDetails.aspx?coType=1&aId=3827
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author Leila Asgarzadeh
Majid Mahallei
Manizheh Mostafa Gharehbaghi
author_facet Leila Asgarzadeh
Majid Mahallei
Manizheh Mostafa Gharehbaghi
author_sort Leila Asgarzadeh
collection DOAJ
description 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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spelling doaj-art-0b9684e24df64c5ea09a21a01ada212c2025-02-06T07:15:51ZengOman Medical Specialty BoardOman Medical Journal1999-768X2070-52042024-07-01394e651e65110.5001/imj.2024.90Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized Clinical TrialLeila Asgarzadeh0Majid Mahallei1Manizheh Mostafa Gharehbaghi2Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, IranPediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, IranPediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, IranObjectives: 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.https://omjournal.org/articleDetails.aspx?coType=1&aId=3827candidiasisfluconazolenystatinprophylaxisvery low birth weight infantsiran
spellingShingle Leila Asgarzadeh
Majid Mahallei
Manizheh Mostafa Gharehbaghi
Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized Clinical Trial
Oman Medical Journal
candidiasis
fluconazole
nystatin
prophylaxis
very low birth weight infants
iran
title Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized Clinical Trial
title_full Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized Clinical Trial
title_fullStr Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized Clinical Trial
title_full_unstemmed Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized Clinical Trial
title_short Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized Clinical Trial
title_sort comparing fluconazole and nystatin as antifungal prophylactics in very low birth weight infants a randomized clinical trial
topic candidiasis
fluconazole
nystatin
prophylaxis
very low birth weight infants
iran
url https://omjournal.org/articleDetails.aspx?coType=1&aId=3827
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