Status:
UNKNOWN
Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis
Lead Sponsor:
McMaster University
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Hamilton Health Sciences Corporation
Conditions:
Hydronephrosis
Urinary Tract Infection
Eligibility:
All Genders
1-7 years
Phase:
NA
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 f...
Detailed Description
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 f...
Eligibility Criteria
Inclusion
- 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
- Infants with grades II to V VUR
- Infants with posterior urethral valves or Prune-Belly syndrome
- Duplication anomalies (ureteroceles, ectopic ureters)
- Other conditions that may require chronic use of antibiotics
- Previous renal failure
- Allergy to trimethoprim
- Co-enrollment in another intervention trial
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01140516
Start Date
July 1 2010
End Date
September 1 2024
Last Update
October 19 2023
Active Locations (2)
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1
McMaster Children's Hospital
Hamitlon, Ontario, Canada, L8N 3Z5
2
Sick Kids Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8