Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants with a First Febrile Urinary Tract Infection: a Multi-center Pilot Study
Topical Steroid RCT Pilot
What is the goal of the study?
Aim 1: To determine the feasibility of enrolling participants to a future trial which will determine the effectiveness of topical steroids in preventing recurrent UTIs in uncircumcised male infants after a first UTI. We will measure the number of infants eligible over a 12-month period and the consent rate for those eligible. The number of infants eligible and consent rate will help inform the feasibility of enrolling the target sample size needed to power the future study aims. The feasibility criteria will be a consent rate of ≥ 20% as stratified by setting (inpatient vs. emergency department vs. PCP clinic). This data will help inform the settings in which the trial would be feasible and the total number of institutions that would be needed to power the future multi-center study. We will also measure the number of infants with hydronephrosis to assess the feasibility of conducting a subgroup analysis for this population in the future trial. Aim 2: To measure the preferred modality of follow up study visits at 1 month and 6 months, whether virtual or in-person CRC visits, and measure feasibility of conducting the visits. We will measure the preferred modality for follow up and measure the attrition rate. The attrition rate will help inform sample size for the future study. We will also pilot the structured interview questions during the follow up visits and refine the interview guide for the future study. We will pilot the following retention strategies: creating a study logo/themed materials to create study identity, training study personnel to emphasize the importance of the study and follow ups, having a clear study contact, sending monthly text message reminders with secure link to change preferred contact information and renumeration for study visits. Aim 3: We use semi-structured interviews to attain parent perspectives on the study protocol and outcomes. Parents enrolled in the pilot study will answer questions related to feasibility of the study protocol during the follow up visits and we will ascertain ideas for ways to increase engagement, retention and adherence to topical steroid treatment. We will pilot different ways to measure adherence to treatment (parent diary plus interview questions at 4 week follow up visit). We will also glean perspectives regarding important outcomes to measure in the future trial.
Who can participate in the study?
Please contact the study team listed below to learn more.