Effectiveness of Oral Nystatin Prophylaxis in the Prevention of Candida Colonization in Very Low Birth Weight Preterm Neonates; a Randomized Controlled Trial

Background: The present study aimed to assess the effectiveness of oral nystatin as antifungal prophylaxis in the prevention of fungal colonization in premature neonates admitted to neonatal intensive care units (NICUs). Methods: This randomized controlled trial was conducted on 106 neonates admitted to NICUs in the first 72 h of their life with gestational age, gestational age of fewer than 32 weeks, and birth weight of less than 1500 g. The neonates were randomly assigned to two groups: the case group (received nystatin, n=53) and the control group (did not receive nystatin, n=53). After one week, swabs were prepared from the oral and rectal mucosa of the subjects for smear and fungal culture. Results: The results obtained from the culture revealed that nystatin prophylaxis significantly decreased the colonization of Candida in premature neonates (P=0.03). Moreover, nystatin prophylaxis was significantly associated with Candida colonization in preterm infants with the following characteristics: a gestational age of 28-32 weeks (0 (0.0%) vs. 5 (10.9%)) (P= 0.05), very low birth weight (VLBW) infants (0 (0.0%) vs. 8 (16.0%)) (P=0.007), neonates born via normal vaginal delivery (NVD) (1 (11.1%) vs. 8 (72.7%)) (P=0.01), infants born after preterm rupture of the membrane (PROM) (1 (10.0%) vs. 6 (75.0%)) (P=0.01), and neonates taking broad-spectrum antibiotics (1 (3.7%) vs. 7 (26.9%)) (P=0.02). Conclusion: The present study demonstrated that nystatin prophylaxis might be considered an effective drug in the prevention of Candida colonization and might lower the risk of SFIs; nonetheless, it had no significant effect on extremely low birth weight (ELBW) neonates. Since nystatin is safe, well-tolerated, affordable, and effective, further studies are required to confirm it as a therapeutic option for ELBW newborns with Candida infections.