Topical Steroids to Prevent Recurrent UTIs in Uncircumcised Male Infants
This pilot study is testing if a steroid cream, betamethasone valerate 0.1%, could help prevent repeat urinary tract infections (UTIs) in uncircumcised male infants. The main goal is to see how well we can recruit families for a larger study in the future. Infants up to 5 months old who have had their first UTI with a fever can join. You would apply either the steroid cream or a placebo cream (a cream without medicine) to your baby's foreskin and glans twice a day for four weeks. The study will then follow your baby to see if they get more UTIs and to understand your experience.
- Study design
- This is an interventional pilot study planning to enroll 40 uncircumcised male infants. Participants will be randomly assigned to receive either the active drug or a placebo.
- What's involved
- Participants will apply cream twice a day for four weeks. There will be two follow-up visits: one 28-38 days after enrollment/discharge, and another 6-7 months after enrollment/discharge.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6-7 months after enrollment or hospital discharge to check for UTIs and gather parent feedback.
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Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
At a glance
Conditions
Where it's being run
3 sites across 2 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Feasibility of recruitment across different settingsup to 2 weeks
Defined as the consent rate of \>= 20% as stratified by setting (clinic/EC/inpatient)