Oral nystatin prophylaxis to prevent systemic fungal infection in very low birth weight preterm infants: a randomized controlled trial.

BACKGROUND: Systemic fungal infection (SFI) is one of leading causes of morbidity and mortality in very low birth weight (VLBW) preterm infants. Because early diagnosis of SFI is challenging due to nonspecific manifestations, prophylaxis becomes crucial. This study aimed to assess effectiveness of oral nystatin as an antifungal prophylaxis to prevent SFI in VLBW preterm infants. METHODS: A prospective, open-labelled, randomized controlled trial was performed in a neonatal intensive care unit (NICU) of an academic hospital in Indonesia. 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. 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. The incidence of fungal colonization and SFI were observed and evaluated during the six-week study period. Overall mortality rates and nystatin-related adverse drug reactions during the study period were also documented. RESULTS: A total of 95 patients were enrolled. 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). There were five cases of SFI, all of which were found in the control group (p-value = 0.056). There was no difference in overall mortality between the two groups. No adverse drug reactions were noted during the study period. CONCLUSIONS: Nystatin is effective and safe as an antifungal prophylactic medication in reducing colonization rates in the study population. 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. TRIAL REGISTRATION: NCT03390374. Registered 4 January 2018 - Retrospectively registered.

Closed catheter access system implementation in reducing the bloodstream infection rate in low birth weight preterm infants.

BACKGROUND: Bloodstream infection (BSI) is one of the significant causes of morbidity and mortality encountered in a neonatal intensive care unit, especially in developing countries. Despite the implementation of infection control practices, such as strict hand hygiene, the BSI rate in our hospital is still high. The use of a closed catheter access system to reduce BSI related to intravascular catheter has hitherto never been evaluated in our hospital. OBJECTIVE: To determine the effects of closed catheter access system implementation in reducing the BSI rate in preterm neonates with low birth weight. METHODS: Randomized clinical trial was conducted on 60 low birth weight preterm infants hospitalized in the neonatal unit at Cipto Mangunkusumo Hospital, Jakarta, Indonesia from June to September 2013. Randomized subjects either received a closed or non-closed catheter access system. Subjects were monitored for 2 weeks for the development of BSI based on clinical signs, abnormal infection parameters, and blood culture. RESULTS: Closed catheter access system implementation gave a protective effect toward the occurrence of culture-proven BSI (relative risk 0.095, 95% CI 0.011-0.85, p = 0.026). Risk of culture-proven BSI in the control group was 10.545 (95% CI 1.227-90.662, p = 0.026). BSI occurred in 75% of neonates without risk factors of infection in the control group compared to none in the study group. CONCLUSION: The use of a closed catheter access system reduced the BSI in low birth weight preterm infants. Choosing the right device design, proper disinfection of device, and appropriate frequency of connector change should be done simultaneously.