Abstract
PURPOSE: To determine whether continuous antibiotic prophylaxis (CAP) could prevent urinary tract infection (UTI) in mild to moderate antenatal isolated hydronephrosis (IH), characterized by hydronephrosis without ureter and bladder abnormalities, and anteroposterior renal pelvis diameter <16 mm and the Society for Fetal Urology grade <4, in neonatal renal ultrasound. MATERIALS AND METHODS: Eighty neonates aged 7 to 30 days, with antenatal hydronephrosis and mild to moderate IH on neonatal renal ultrasound, were recruited from August 2015 to December 2016. Neonates were randomly assigned to CAP until hydronephrosis resolution or aged 12 months (CAP group, n=40) or to watchful observation (control group, n=40). The primary outcome was UTI. The probability of UTI was compared between the randomized groups using the Kaplan-Meier method and the log-rank test. RESULTS: Nonadherence occurred in 6/40 parents in the CAP arm (15.0%). Thus, only 34 patients received CAP. UTI occurred in 5/34 patients in the CAP group (14.7%) and in 4/40 controls (10.0%). The probability of UTI was increased in the CAP group (hazard ratio, 1.38; 95% confidence interval, 0.37-5.16; p=0.63). UTI caused by cotrimoxazole resistant bacteria was four times higher in the CAP group than in controls (relative risk, 4.0; 95% confidence interval, 1.2-13.5; p=0.02). The trial was prematurely terminated due to the negative impact of CAP on bacterial sensitivity. CONCLUSIONS: The benefits of CAP in infants with mild to moderate IH were inconclusive. CAP conferred a high risk of resistant bacterial organisms when UTI occurs.