Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis (ALPHA)
This study is currently recruiting participants.
Verified January 2013 by McMaster University
Sponsor:
McMaster University
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: January 21, 2013
Last verified: January 2013
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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 5 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
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
- Solitary kidney
- Allergy to trimethoprim
- Co-enrollment in another intervention trial
Contacts and Locations
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: Keith Lau, MD FAAP MB | |
| 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 | Not yet recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Armando J Lorenzo, MD (416) 813-6465 armando.lorenzo@sickkids.ca | |
| Contact: Rachel Donen, MA (416) 813-7600 ext 2419 rachel.donen@sickkids.ca | |
| Principal Investigator: Armando J Lorenzo, MD | |
| Sub-Investigator: Martin Koyle | |
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: | January 21, 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 Trimethoprim Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions 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 June 18, 2013