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Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis

NCT01140516 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-10-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trimethoprim

2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.

OTHER

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

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • McMaster Surgical Associates

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • Luis H Braga, MD, MSc, PhD · McMaster Medical Centre, McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
7 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01140516 on ClinicalTrials.gov