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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 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: July 2, 2015
Last verified: July 2015

June 8, 2010
July 2, 2015
July 2010
June 2016   (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
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
1 Month to 7 Months
No
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
 
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
July 2015

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