What this study is
The goal of this smaller clinical trial is to evaluate the study design of this research to help prepare for a larger research study in the future. The future larger study would focus on whether steroid cream can reduce recurrent urinary tract infections in male infants, who are not circumcised.
Male infants, who are enrolled in this study, would receive either the steroid cream or a placebo cream (a look alike cream without steroids). The cream would be applied twice a week for four weeks. Then there would be two follow up visits with the research team to measure whether the infant experienced any urinary tract infections and to measure parent perceptions of their experience participating in the study.
What's being tested
- betamethasone valerate 0.1% cream
Intervention · DRUG
Steroid cream applied to the foreskin and glans twice a day for four weeks.
- Placebo cream
Intervention · DRUG
Placebo cream is applied to the foreskin and glans twice a day for four weeks.
Study details
- Official title
- Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants With a First Febrile Urinary Tract Infection: a Multi-center Pilot Study
- Sponsor
- Baylor College of Medicine
- Conditions
- Urinary Tract Infection
- Enrolling
- 40 people
- Starts
- 2026-04
- Est. completion
- 2027-12
- Design
- Quadruple-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Months – 5 MonthsSex MALEHealthy volunteers Not acceptedYou may qualify if
- Uncircumcised male infants < 6 months old
- Both physician and laboratory confirmed diagnosis of first UTI
- Fever (temperature ≥38.0 C) or hypothermia (temperature <36.0 C) per ED/hospitalization or parental report
You can't join if
- Legal guardian not available to provide informed consent
- Infant in Child Protective Services (CPS) custody
- Legal guardian would like Urology referral for circumcision
- Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination
- Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee))
- Prior use of topical steroid therapy for phimosis
- History of hypersensitivity to topical steroids
- Legal guardian is not fluent in English OR Spanish
- Foreskin assessed to be fully retractable
- Open wounds present on penis or in groin region
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for 2 of 3 open sites
- Sowdhamini Wallace, DO, MS · Contact832-824-5447swallace@bcm.edu
- Sowdhamini Wallace, DO, MS · Principal investigator
Texas Children's Hospital Main campus
Houston, Texas, United States
- Grace Truong, MD · Sub-investigator
- Chester Koh, MD, MBA · Sub-investigator
- Jaqueline Broda, MPAS, PA-C · Sub-investigator
- Saamia Masoom, MD · Sub-investigator
RecruitingTexas Children's Hospital West Campus
Katy, Texas, United States
- Marina Bishai, DO · Sub-investigator
Not yet recruitingSeattle Children's Hospital
Seattle, Washington, United States
- Eric Coon, MD, MS · ContactEric.Coon@seattlechildrens.org
- Eric Coon, MD, MS · Principal investigator
Not yet recruiting
Study team
Sponsor
Baylor College of Medicine
Study ID H-57427
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.