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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Oman Medical Specialty Board
2024-07-01
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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. |
format | Article |
id | doaj-art-0b9684e24df64c5ea09a21a01ada212c |
institution | Kabale University |
issn | 1999-768X 2070-5204 |
language | English |
publishDate | 2024-07-01 |
publisher | Oman Medical Specialty Board |
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series | Oman Medical Journal |
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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