Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis

NCT01140516 | Unknown DMC

• 1 other identifier: ALPHA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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 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

Hydronephrosis; Urinary Tract Infection

Keywords

Antenatal

Outcome Measures

Primary Outcomes (1)

• To determine whether antibiotics (ATB) prophylaxis prevents urinary tract infection (UTI) in infants with antenatal hydronephrosis (AHN).

  Determine the rate and frequence of UTI infection

  The outcome measures will be assessed at 12 months

Study Arms (2)

Trimethoprim

ACTIVE COMPARATOR

Prophylactic Antibiotics

Drug: Trimethoprim

Simple syrup

PLACEBO COMPARATOR

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

Other: Simple Syrup

Interventions

Trimethoprim DRUG

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

Trimethoprim

Simple Syrup OTHER

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

Simple syrup

Eligibility Criteria

• Age: 1 Month - 7 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• The Physicians' Services Incorporated Foundation: collaborator
• Hamilton Health Sciences Corporation: collaborator
• McMaster Surgical Associates: collaborator

Study Sites (2)

McMaster Children's Hospital

Hamitlon, Ontario, L8N 3Z5, Canada

Location

Sick Kids Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Hydronephrosis; Urinary Tract Infections

Interventions

Trimethoprim

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Luis H Braga, MD, MSc, PhD

  McMaster Medical Centre, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 9, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

CA (2)