بررسی اثر فلوکونازول در پیشگیری از عفونت قارچی و مرگ و میر نوزادان با وزن خیلی کم بستری در بخش مراقبت‌های ویژه نوزادان:کارآزمایی بالینی

Background: Fungal infections especially Candida species are frequent cause of mortality and morbidity in very low-birth-weight (VLBW) infants receiving intensive care; Candida infections are tissue invasive. This infection increases the risks of adverse neurodevelopmental sequelae. Prevention and treatment of fungal infection is so important in very VLBW infants. The aim of this study was to determine the prophylactic effect of fluconazole in decreasing the mortality and morbidity in VLBW infants (less than 1500gr) admitted in NICU. Methods: This prospective case control study were conducted among 102 Infants (weighing less than 1500gr at birth at born) admitted in NICU department of Ali Asghar University Hospital from 2012 to 2013, Tehran, Iran. Weigh of birth in cases and groups were less than 1500 gr and both were culture negative. Cases received oral fluconazole 3 mg/kg in 3 days in 1st and 2nd weeks, alternate day in 3rd and 4th weeks, daily in 5th and 6th weeks. Control groups had not received fluconazole. Mortality and morbidity and hospital stay were compared between cases and controls groups. Results: We studied 49 very low-birth-weight infants with negative culture as cases (received fluconazole prophylaxis), 46 VLBW infants without fluconazole profilaxy (controls). No significant difference in gestational age (P=0.2), and mean weights (P=0.4) were observed between cases and controls. The mortality rate 8.7% (n=4) in controls (without prophylactic fluconazole) observed vs 2% (n=1) mortality rate in VLBW cases (with prophylactic fluconazole). Although the mortality rate in controls was 4 times higher than cases, but without significant differences (P=0.1). Indeed, mean duration of hospital stay in controls was longer than cases (28.41±9.93 vs 19.85±6.19 days, P=0.00001). Conclusion: Although prophylactic fluconazole in VLBW could decrease the mortality of cases (control the fungal infection) 4 fold in compare with controls (no treatment), it was not significant. The prophylactic effect of fluconazole might decrease the length of hospital stay of VLBW neonates in NICU. Due to limited number of cases and control. For further decision about prophylactic use of fluconazole, prospective RCT studies with larger cases and control would be helpful in future.