Pilot Study of Steroid Cream to Prevent Repeat Urinary Tract Infections in Uncircumcised Male Infants Under 6 Months

What this Trial Is About

This research aims to assess the study design to prepare for a larger future trial investigating whether steroid cream can reduce recurrent urinary tract infections in uncircumcised male infants under 6 months old. The study focuses on infants who have had their first urinary tract infection confirmed by both physician and laboratory tests. It is a multi-center pilot study involving recruitment from outpatient clinics, emergency departments, and hospitals in Texas and Washington. Participants will be randomly assigned to receive either a steroid cream betamethasone valerate 0.1% or a placebo cream that looks identical, applied twice daily to the foreskin and glans for four weeks. Hospitalized infants will be enrolled before discharge, while others will be enrolled in a clinical research center. The legal guardians will be taught how to apply the cream. After treatment, there will be two follow-up visits the first 28 to 38 days after enrollment or hospital discharge, and the second visit 6 to 7 months later. During the study, researchers will monitor the feasibility of recruiting participants, track rates and numbers of recurrent urinary tract infections, hospitalizations, emergency visits, and other related medical events over six months. They will also assess parental acceptability and adherence to the cream application. Safety, including adverse effects of the cream, will be evaluated at four weeks. Overall participation will last about 6 to 7 months, with detailed follow-up and data collection throughout this period.

Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study