Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis (ALPHA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by McMaster University
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Hamilton Health Sciences Corporation
McMaster Surgical Associates
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01140516
First received: June 8, 2010
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Hydronephrosis
Urinary Tract Infection
Drug: Trimethoprim
Other: Simple Syrup

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotic prophyLaxis Versus Placebo in Infants Diagnosed With Hydronephrosis Antenatally

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • To determine whether antibiotics (ATB) prophylaxis prevents urinary tract infection (UTI) in infants with antenatal hydronephrosis (AHN). [ Time Frame: The outcome measures will be assessed at 12 months ] [ Designated as safety issue: No ]
    Determine the rate and frequence of UTI infection


Estimated Enrollment: 160
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trimethoprim
Prophylactic Antibiotics
Drug: Trimethoprim
2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.
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.
Other: Simple Syrup
2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.

  Eligibility

Ages Eligible for Study:   up to 7 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants with AHN confirmed postnatally with renal-bladder ultrasound
  • Unilateral Society for Fetal Urology (SFU) grade III and IV AHN (high grade hydronephrosis)and/or dilated ureter of 7mm or greater
  • Patients without vesico-ureteral reflux (VUR) determined by voiding cystogram - uretero pelvic junction obstruction-like (UPJO-like) and primary megaureter (hydroureteronephrosis)
  • Parent or legal guardian able to give free and informed consent
  • Infants up to 7 months of age

Exclusion Criteria:

  • Vesicoureteral Reflux (VUR) grades II to V
  • Infants with posterior urethral valves, Prune-Belly syndrome
  • Duplication anomalies (ureteroceles, ectopic ureters)
  • Other conditions that may require chronic use of antibiotic
  • Previous Renal failure
  • Allergy to trimethoprim
  • Co-enrollment in another intervention trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140516

Contacts
Contact: Luis Braga, MD 905-521-2100 ext 73777 lhpbraga@gmail.com
Contact: Julia Pemberton, MSc 905-521-2100 ext 76692 pemberj@mcmaster.ca

Locations
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamitlon, Ontario, Canada, L8N 3Z5
Contact: Luis H Braga, MD, MSc, PhD    905-521-2100 ext 73777    lhpbraga@gmail.com   
Contact: Julia Pemberton, MSc    905-521-2100 ext 76692    pemberj@mcmaster.ca   
Sub-Investigator: Jorge DeMaria, FRCS(c) FAAP         
Sub-Investigator: Forough Farrokhyar, MPhil, PhD         
Sub-Investigator: Lucy Giglia, MSc MD FRCPC         
Sub-Investigator: Julia Pemberton, Hon BSc MSc         
Sub-Investigator: Martha B Fulford, MSc MD FRCPC         
Principal Investigator: Luis H Braga, MD PhD         
Sick Kids Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Norman Rosenblum, MD    (416) 813-7654 ext 305667    norman.rosenblum@sickkids.ca   
Contact: Theresa Thompson    (416) 813-5829    theresa.thompson@sickkids.ca   
Sub-Investigator: Armando J Lorenzo, MD         
Principal Investigator: Norman Rosenblum, MD         
Sponsors and Collaborators
McMaster University
The Physicians' Services Incorporated Foundation
Hamilton Health Sciences Corporation
McMaster Surgical Associates
Investigators
Principal Investigator: Luis H Braga, MD, MSc, PhD McMaster Medical Centre, McMaster University
  More Information

Additional Information:
No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01140516     History of Changes
Other Study ID Numbers: ALPHA
Study First Received: June 8, 2010
Last Updated: November 4, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Antenatal

Additional relevant MeSH terms:
Hydronephrosis
Urinary Tract Infections
Kidney Diseases
Urologic Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Trimethoprim
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014