Clinical Trial: Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Antibiotic prophyLaxis Versus Placebo in Infants Diagnosed With Hydronephrosis Antenatally

Brief Summary: This study focuses on the relationship between prophylaxis antibiotics and frequency of urinary tract infection in children diagnosed with antenatal hydronephrosis. Hydronephrosis is the most common fetal abnormality occurring in 1-5% of all pregnancies. Currently, with the widespread accessibility of antenatal ultrasound across cities in Ontario, the detection of hydronephrosis has become even more common. As a result, thousands of infants with hydronephrosis have been seen and managed by pediatricians, pediatric nephrologists, pediatric urologists, and family physicians. The investigators need to determine if antibiotic prophylaxis is effective in reducing the number of urinary tract infections in this population.

Detailed Summary:
Sponsor: McMaster University

Current Primary Outcome: To determine whether antibiotics (ATB) prophylaxis prevents urinary tract infection (UTI) in infants with antenatal hydronephrosis (AHN). [ Time Frame: The outcome measures will be assessed at 12 months ]

Determine the rate and frequence of UTI infection


Original Primary Outcome: To determine the feasibility of conducting a large definitive randomized controlled study in this population [ Time Frame: The outcome measures will be assessed at 12 months ]

Protocol deviation, screening and recruitment logs will be used to measure outcome.


Current Secondary Outcome:

Original Secondary Outcome: To explore if antibiotic prophylaxis prevents renal scarring [ Time Frame: 12 months ]

Information By: McMaster University

Dates:
Date Received: June 8, 2010
Date Started: July 2010
Date Completion: June 2016
Last Updated: March 21, 2016
Last Verified: March 2016