![]() ![]() Registered 4 January 2018 - Retrospectively registered. Whilst the use of nystatin showed a potential protective effect against SFI among VLBW preterm infants, there was no statistical significant difference in SFI rates between groups. Nystatin is effective and safe as an antifungal prophylactic medication in reducing colonization rates in the study population. ![]() No adverse drug reactions were noted during the study period. There was no difference in overall mortality between the two groups. There were five cases of SFI, all of which were found in the control group (p-value = 0.056). The incidence of fungal colonization was lower among infants in nystatin group compared to those in control group (29.8 and 56.3%, respectively relative risk 0.559 95% confidence interval 0.357–0.899 p-value = 0.009). ResultsĪ total of 95 patients were enrolled. Overall mortality rates and nystatin-related adverse drug reactions during the study period were also documented. The incidence of fungal colonization and SFI were observed and evaluated during the six-week study period. The intervention group received 1 ml of oral nystatin three times a day, and the control group received a dose of 1 ml of sterile water three times a day. Infants with a gestational age ≤ 32 weeks and/or birth weight of ≤ 1500 g with risk factors for fungal infection were assessed for eligibility and randomized to either an intervention group (nystatin) or control group. MethodsĪ prospective, open-labelled, randomized controlled trial was performed in a neonatal intensive care unit (NICU) of an academic hospital in Indonesia. This study aimed to assess effectiveness of oral nystatin as an antifungal prophylaxis to prevent SFI in VLBW preterm infants. Because early diagnosis of SFI is challenging due to nonspecific manifestations, prophylaxis becomes crucial. Systemic fungal infection (SFI) is one of leading causes of morbidity and mortality in very low birth weight (VLBW) preterm infants. ![]()
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