Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants With a First Febrile Urinary Tract Infection: a Multi-center Pilot Study
Baylor College of Medicine
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.
Description
This is a multi-center pilot study involving recruitment of uncircumcised male infants \< 6 months of age from outpatient clinics, emergency department and inpatient settings in Houston, Texas. Additionally, the pilot study will involve recruitment of hospitalized infants from Seattle Children's Hospital in Seattle, Washington. Various strategies for screening and recruitment will be piloted across settings to identify the most effective processes for the future study. Hospitalized infants would be enrolled prior to discharge. Children recruited from the clinic or emergency department would b…
Eligibility
- Age range
- 0–0 years
- Sex
- Male
- Healthy volunteers
- No
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 abnormali…
Interventions
- Drugbetamethasone valerate 0.1% cream
Steroid cream applied to the foreskin and glans twice a day for four weeks.
- DrugPlacebo cream
Placebo cream is applied to the foreskin and glans twice a day for four weeks.
Locations (3)
- Texas Children's Hospital Main campusHouston, Texas
- Texas Children's Hospital West CampusKaty, Texas
- Seattle Children's HospitalSeattle, Washington