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RECRUITINGPhase 4INTERVENTIONAL

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

Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants With a First Febrile Urinary Tract Infection: a Multi-center Pilot Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Uncircumcised male infants \< 6 months old 2. Both physician and laboratory confirmed diagnosis of first UTI 3. Fever (temperature ≥38.0 C) or hypothermia (temperature \<36.0 C) per ED/hospitalization or parental report Who Should NOT Join This Trial: 1. Legal guardian not available to provide willing to sign a consent form 2. Infant in Child Protective Services (CPS) custody 3. Legal guardian would like Urology referral for circumcision 4. Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination 5. Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee)) 6. Prior use of topical steroid therapy for phimosis 7. History of hypersensitivity to topical steroids 8. Legal guardian is not fluent in English OR Spanish 9. Foreskin assessed to be fully retractable 10. Open wounds present on penis or in groin region Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Uncircumcised male infants \< 6 months old 2. Both physician and laboratory confirmed diagnosis of first UTI 3. Fever (temperature ≥38.0 C) or hypothermia (temperature \<36.0 C) per ED/hospitalization or parental report Exclusion Criteria: 1. Legal guardian not available to provide informed consent 2. Infant in Child Protective Services (CPS) custody 3. Legal guardian would like Urology referral for circumcision 4. Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination 5. Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee)) 6. Prior use of topical steroid therapy for phimosis 7. History of hypersensitivity to topical steroids 8. Legal guardian is not fluent in English OR Spanish 9. Foreskin assessed to be fully retractable 10. Open wounds present on penis or in groin region

Treatments Being Tested

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