Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis (NCT01140516) | Clinical Trial Compass
UnknownNot Applicable
Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis
Canada160 participantsStarted 2010-07
Plain-language 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.
Who can participate
Age range1 Month – 7 Months
SexALL
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Inclusion criteria
✓. Infants with AHN (one to seven months of age) confirmed postnatally with renal-bladder ultrasound and/or a dilated ureter ≥ 7mm
✓. SFU grade III and IV AHN (high grade hydronephrosis)
✓. Patients without grades II to V VUR determined by voiding cystogram (includes UPJO-like and primary megaureter (hydroureteronephrosis) only);
✓. Parent or legal guardian able to give free and informed consent
Exclusion criteria
✕. Infants with grades II to V VUR
✕. Infants with posterior urethral valves or Prune-Belly syndrome