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RECRUITING
NCT07508124
PHASE4

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

Sponsor: Baylor College of Medicine

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

MALE

Age Range

0 Months - 5 Months

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-04

Completion Date

2027-12

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

betamethasone valerate 0.1% cream

Steroid cream applied to the foreskin and glans twice a day for four weeks.

DRUG

Placebo cream

Placebo cream is applied to the foreskin and glans twice a day for four weeks.

Locations (3)

Texas Children's Hospital Main campus

Houston, Texas, United States

Texas Children's Hospital West Campus

Katy, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States