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 range
1 Month – 7 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine whether antibiotics (ATB) prophylaxis prevents urinary tract infection (UTI) in infants with antenatal hydronephrosis (AHN).
Timeframe: The outcome measures will be assessed at 12 months