Antibiotic prophyLaxis Versus Placebo in Infants Diagnosed With Hydronephrosis Antenatally

Status: Active, not recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 7 months
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Canada
McMaster Children's Hospital
Hamitlon
Sick Kids Hospital for Sick Children
Toronto
Time Frame
Start Date: July 2010
Estimated Completion Date: September 2023
Participants
Target number of participants: 160
Treatments
Active Comparator: Trimethoprim
Prophylactic Antibiotics
Placebo Comparator: Simple syrup
2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.
Sponsors
Collaborators: The Physicians' Services Incorporated Foundation, McMaster Surgical Associates, Hamilton Health Sciences Corporation
Leads: McMaster University

This content was sourced from clinicaltrials.gov

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