Actively Recruiting
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Led by Baylor College of Medicine · Updated on 2026-04-02
40
Participants Needed
3
Research Sites
87 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
S
Seattle Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Uncircumcised male infants younger than 6 months old
- Confirmed first urinary tract infection diagnosed by both physician and laboratory tests
- Fever of 38.0°C or higher, or low body temperature below 36.0°C during emergency or hospital stay, or reported by parent
You will not qualify if you...
- Legal guardian unavailable to provide consent
- Infant is in Child Protective Services custody
- Guardian requests urology referral for circumcision
- Medical need for circumcision due to recurrent balanitis or ballooning of foreskin when urinating
- Past diagnosis of penile abnormalities such as epispadius, hypospadias, or congenital penile curvature
- Prior use of topical steroid therapy for phimosis
- History of allergy to topical steroids
- Legal guardian not fluent in English or Spanish
- Foreskin is fully retractable
- Presence of open wounds on the penis or groin area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Texas Children's Hospital Main campus
Houston, Texas, United States, 77030
Actively Recruiting
2
Texas Children's Hospital West Campus
Katy, Texas, United States, 77094
Not Yet Recruiting
3
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
Research Team
S
Sowdhamini Wallace, DO, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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