Societies for Pediatric Urology Societies for Pediatric Urology

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Feasibility of conducting a prospective blinded randomized placebo controlled trial to investigate the effect of antibiotic prophylaxis (AP) on the rate of urinary tract infection (UTI) in infants with antenatal hydronephrosis (AHN): the ALPHA pilot study
Luis H Braga*, Julia Pemberton, Jessie Heaman, Jorge DeMaria, Hamilton, Canada, Armando J Lorenzo, Toronto, Canada

INTRODUCTION AND OBJECTIVES: Current guidelines surrounding the use of AP for prevention of UTIs in AHN patients is based on low levels of evidence. To determine the feasibility of conducting a clinical trial on this topic, a blinded randomized placebo controlled trial investigating the rate of UTIs in infants with grades III and IV AHN was piloted at our institution.

METHODS: Recruitment began in August 2010, and is still ongoing. Exclusion criteria were grades I/II AHN, presence of VUR, duplication anomalies and age at randomization >5 mos. Prospectively feasibility data on eligibility and enrollment status, adherence to follow-up schedule, and medication and protocol compliance were collected at baseline and monthly during the 12- month follow-up period (4 clinic visits and 8 telephone calls). To determine medication compliance families were provided monthly medication logs and asked to record when drug was administered.

RESULTS: Of 215 AHN patients screened, 61 met the studyís eligibility criteria (28%), 150 (70%) were ineligible, 2 (1%) are waiting for VCUG, and 2 (1%) missed the randomization window. Of the 61 eligible patients, 36 were enrolled (59%), 24 declined (39%) and 1 is pending consent (2%). Reasons for declining participation included parents either wanting or not wanting their children to be on AP, or families not wanting their children to participate in research. Of the 36 enrolled patients, 18 (50%) completed the trial, 14 (39%) are still in follow-up and 4 (11%) dropped out. Of the 18 patients who completed the trial, 3 (14%) developed a confirmed febrile UTI. A total of 218 medication logs were provided to families and 176 (81%; 95%CI: 75-86%) have been completed and returned. Of these returned medication logs, average compliance was 95% (95%CI: 89-98%). Of the 32 families whose children have completed the study or are still in follow-up, 20 (63%; 95%CI: 45-77%) administered study medication at least 75% of the time. Adherence to the trialís follow up schedule was 93% (95%CI: 86-97%).

CONCLUSIONS: High level research is needed to define evidence-based guidelines for AP use in patients with AHN. Due to low outcome rate, multi-centre collaboration is critical to address the effect of AP on UTI rate in this population. Feasibility results demonstrate reasonable medication compliance, high adherence to follow-up schedule and a realistic recruitment rate for this group of patients, making a definitive trial on this topic feasible.
Source of Funding: New Investigator Fund (NIF)from Hamilton Health Sciences (McMaster University)

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