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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age0-5
SponsorBaylor College of Medicine

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • betamethasone valerate 0.1% cream
  • Placebo cream

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Baylor College of Medicine

Lead sponsor

Seattle Children's Hospital

Collaborator