Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation; McMaster Surgical Associates; The Physicians' Services Incorporated Foundation
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Trimethoprim

Criteria

Inclusion Criteria:

1. Infants with AHN (one to seven months of age) confirmed postnatally with renal-bladder ultrasound and/or a dilated ureter ≥ 7mm

2. SFU grade III and IV AHN (high grade hydronephrosis)

3. Patients without grades II to V VUR determined by voiding cystogram (includes UPJO-like and primary megaureter (hydroureteronephrosis) only);

4. Parent or legal guardian able to give free and informed consent

Exclusion Criteria:

1. Infants with grades II to V VUR

2. Infants with posterior urethral valves or Prune-Belly syndrome

3. Duplication anomalies (ureteroceles, ectopic ureters)

4. Other conditions that may require chronic use of antibiotics

5. Previous renal failure

6. Allergy to trimethoprim

7. Co-enrollment in another intervention trial