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

June 8, 2010
November 4, 2013
July 2010
December 2014   (final data collection date for primary outcome measure)
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
To determine the feasibility of conducting a large definitive randomized controlled study in this population [ Time Frame: The outcome measures will be assessed at 12 months ] [ Designated as safety issue: No ]
Protocol deviation, screening and recruitment logs will be used to measure outcome.
Complete list of historical versions of study NCT01140516 on ClinicalTrials.gov Archive Site
Not Provided
To explore if antibiotic prophylaxis prevents renal scarring [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis
Antibiotic prophyLaxis Versus Placebo in Infants Diagnosed With Hydronephrosis Antenatally

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hydronephrosis
  • Urinary Tract Infection
  • 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.
  • Active Comparator: Trimethoprim
    Prophylactic Antibiotics
    Intervention: Drug: Trimethoprim
  • 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.
    Intervention: Other: Simple Syrup
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
up to 7 Months
No
Contact: Luis Braga, MD 905-521-2100 ext 73777 lhpbraga@gmail.com
Contact: Julia Pemberton, MSc 905-521-2100 ext 76692 pemberj@mcmaster.ca
Canada
 
NCT01140516
ALPHA
Yes
McMaster University
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
McMaster University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP