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.
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 be enrolled in the Texas Children's Hospital Clinical Research Center. Randomization would occur after enrollment and would be conducted by the investigational pharmacy. The research investigators will teach the legal guardians of the infants how to apply the cream. The first follow up visit would occur after completion of the cream treatment and would be 28-38 days after being enrolled or after hospital discharge, whichever came later. The last follow up visit would occur 6-7 months after being enrolled or hospital discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Steroid cream applied to the foreskin and glans twice a day for four weeks.
Placebo cream is applied to the foreskin and glans twice a day for four weeks.
Texas Children's Hospital Main campus
Houston, Texas, United States
RECRUITINGTexas Children's Hospital West Campus
Katy, Texas, United States
NOT_YET_RECRUITINGSeattle Children's Hospital
Seattle, Washington, United States
NOT_YET_RECRUITINGFeasibility of recruitment across different settings
Defined as the consent rate of \>= 20% as stratified by setting (clinic/EC/inpatient)
Time frame: up to 2 weeks
Rate of recurrent urinary tract infection
Defined as at least one subsequent urinary tract infection as confirmed through parent report and medical record review.
Time frame: Between 14 days of completing antibiotics for the first urinary tract infection and through the last follow up visit, which occurs 6 months after randomization.
Total number of recurrent urinary tract infections
Time frame: 6 month follow up period
Number of subsequent hospitalizations for recurrent urinary tract infections
Subsequent hospitalizations for recurrent urinary tract infections
Time frame: 6 month follow up period
Number of subsequent emergency department visits for recurrent urinary tract infection
Subsequent emergency department visits, including urgent care, for recurrent UTI
Time frame: Within 6 month follow up period
Rate of provider diagnosed recurrent urinary tract infection
Number of recurrent urinary tract infections that are diagnosed by the physician but do not necessarily meet laboratory criteria for urinary tract infection.
Time frame: 6 month follow up period
Number of Lumbar punctures
Number of lumbar punctures received during a subsequent emergency department visit or hospitalization for recurrent urinary tract infection
Time frame: 6 month follow up period
Self reported Rate of Referral for Circumcision
Parent reports referral to Urology for circumcision or circumcision performed within the 6 month follow up period.
Time frame: During the 6 month follow up period
Self Reported Adherence to Applying Topical Cream Regimen
Adherence to applying the topical cream measured by asking the frequency of application in a questionnaire completed by the legal guardian.
Time frame: Measured at 4 week follow up visit
Rate of Adverse effects of cream
Local or systemic side effects of the cream (e.g., irritation, local infection)
Time frame: At 4 weeks
Number of infants with Congenital anomalies of the kidney and urinary tract
Number of participants with previously known or newly diagnosed genitourinary anomalies
Time frame: From time of enrollment through last follow up visits 6 months later
Number of subsequent clinic visits for recurrent urinary tract infection
Subsequent clinic visits may include visits to the primary care physician or another physician in the clinic
Time frame: During the 6 month follow up period
Attrition rate
Total number of missed visits at 4 weeks and 6 months. This will be measured by tracking of study visits.
Time frame: Through the 6 month follow up period for each participant
Parental acceptability of the study design
Perceptions on any facilitators and barriers to participating in the study as related to enrollment, administration of the study cream and attending follow up visits. Qualitatively measured using semi-structured interviews.
Time frame: At the 6 month follow up visit for each participant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.