Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection

Background: Preterm and low birth weight infants have an immature immune system that predisposes them to infections. Broad-spectrum antibiotics, steroids, central venous catheters, endotracheal intubation, and abdominal surgery increase the risk of invasive candidiasis. Prophylactic fluconazole therapy may be helpful in the prevention of invasive candida infection. Objective: To determine the efficacy of prophylactic fluconazole therapy in preterm and very low birth weight infants in the prevention of invasive candida infection.Methods: A randomized clinical trial (ClinicalTrials.gov ID NCT05848492) was conducted at the Neonatal Unit of Services Hospital Lahore, Pakistan, from May 1st, 2021 to October 31st, 2021. A total of 110 neonates were recruited for the study. Neonates were divided into a fluconazole prophylaxis group and a control group. The efficacy of fluconazole was determined based on its ability to prevent the development of invasive candida infection. Data were collected using an online form created in Google Forms, and analysis was conducted using PSPP version 1.4 for descriptive data and Open Source Epidemiologic Statistics for Public Health (OpenEpi) version 3.0 for calculating p-values.Results: The majority of the neonates were between 32 to 34 weeks of gestational age. Cesarean section was the most common mode of delivery (58.6%). 50% of the babies had a history of preterm premature rupture of membranes (PPROM). All infants received broad-spectrum antibiotics. 1 neonate in the fluconazole prophylaxis group while 3 neonates in the placebo group developed invasive candidiasis. Statistical analysis using the Yates-corrected chi-square test found no significant difference in preventing invasive candidiasis between the fluconazole group and the control group in the study population. Conclusion: The study conducted at our center found that prophylactic fluconazole therapy did not show a significant difference in preventing invasive candidiasis in preterm and very low birth weight (VLBW) neonates.