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

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ClinicalTrials.gov Identifier: NCT01140516
Recruitment Status : Recruiting
First Posted : June 9, 2010
Last Update Posted : August 30, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hydronephrosis Urinary Tract Infection Drug: Trimethoprim Other: Simple Syrup

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotic prophyLaxis Versus Placebo in Infants Diagnosed With Hydronephrosis Antenatally
Study Start Date : July 2010
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    Determine the rate and frequence of UTI infection

Eligibility Criteria

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Ages Eligible for Study:   1 Month to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140516

Contact: Luis Braga, MD 905-521-2100 ext 73777 lhpbraga@gmail.com
Contact: Bethany Easterbrook, BSc, MSc(c) 905-521-2100 ext 76692 easterb@mcmaster.ca

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: Bethany Easterbrook, B. Kin    905-521-2100 ext 76692    easterb@mcmaster.ca   
Sub-Investigator: Jorge DeMaria, FRCS(c) FAAP         
Sub-Investigator: Forough Farrokhyar, MPhil, PhD         
Sub-Investigator: Lucy Giglia, MSc MD FRCPC         
Sub-Investigator: Natasha Brownrigg, RN, MN         
Sub-Investigator: Martha B Fulford, MSc MD FRCPC         
Principal Investigator: Luis H Braga, MD PhD         
Sub-Investigator: Mandy Rickard, RN, MN         
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
Principal Investigator: Luis H Braga, MD, MSc, PhD McMaster Medical Centre, McMaster University
More Information

Additional Information:
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01140516     History of Changes
Other Study ID Numbers: ALPHA
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by McMaster University:

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases
Kidney Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors