Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants With a First Febrile Urinary Tract Infection: a Multi-center Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Feasibility of recruitment across different settings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Months 至 5 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee))
- •Prior use of topical steroid therapy for phimosis
- •History of hypersensitivity to topical steroids
- •Legal guardian is not fluent in English OR Spanish
- •Foreskin assessed to be fully retractable
- •Open wounds present on penis or in groin region
研究组 & 干预措施
Participants randomized to receive steroid cream
干预措施: betamethasone valerate 0.1% cream (Drug)
Participants randomized to receive placebo cream.
干预措施: Placebo cream (Drug)
结局指标
主要结局
Feasibility of recruitment across different settings
时间窗: up to 2 weeks
Defined as the consent rate of \>= 20% as stratified by setting (clinic/EC/inpatient)
次要结局
- Rate of recurrent urinary tract infection(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(6 month follow up period)
- Number of subsequent hospitalizations for recurrent urinary tract infections(6 month follow up period)
- Number of subsequent emergency department visits for recurrent urinary tract infection(Within 6 month follow up period)
- Rate of provider diagnosed recurrent urinary tract infection(6 month follow up period)
- Number of Lumbar punctures(6 month follow up period)
- Self reported Rate of Referral for Circumcision(During the 6 month follow up period)
- Self Reported Adherence to Applying Topical Cream Regimen(Measured at 4 week follow up visit)
- Rate of Adverse effects of cream(At 4 weeks)
- Number of infants with Congenital anomalies of the kidney and urinary tract(From time of enrollment through last follow up visits 6 months later)
- Number of subsequent clinic visits for recurrent urinary tract infection(During the 6 month follow up period)
- Attrition rate(Through the 6 month follow up period for each participant)
- Parental acceptability of the study design(At the 6 month follow up visit for each participant)
研究者
Sowdhamini Wallace
Associate Professor of Pediatrics
Baylor College of Medicine