Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract (PREDICT)
Vesicoureteral Reflux, Renal Hypodysplasia, Nonsyndromic, 1, Chronic Kidney Disease
About this trial
This is an interventional prevention trial for Vesicoureteral Reflux focused on measuring antibiotic prophylaxis, vesicoureteral reflux, congenital abnormalities of kidney, renal hypodysplasia, chronic kidney disease
Eligibility Criteria
Inclusion Criteria:
- Age between 1 and 4 months (> 4 weeks and <20 weeks of post-natal age)
- Gestational age > 35 weeks
- Glomerular filtration rate (calculated according to Schwartz) > 15 ml/min/1.73 m2
- No previous symptomatic UTI
- Imaging Diagnostic work-up completed and presence of grade III to V vesicoureteral reflux
- Informed consent of parents
Exclusion Criteria:
- Age <1 and >4 months
- Gestational age < 35 weeks
- Glomerular filtration rate (calculated according to Schwartz) < 15 ml/min/1.73 m2 at three months of age
- Patients with neurogenic bladder, myelomeningocele, ureteropelvic junction and/or ureterovesical junction obstruction, or other malformations leading to potential voiding disturbances.
- Presence of urethral valves
- Patients with no or low grade reflux (grade I and II).
- Hypersensitivity to the all the utilized antimicrobial agent
- Children with serious clinical conditions which, according to the investigator, prevent them from being included in the study cohort.
- Use of experimental drugs in the month previous to the beginning of the study
- Children unable to follow the established protocol procedures or whose parents are unable to sign the informed consent.
Sites / Locations
- Pediatric Nephrology Dialysis and Transplant Unit IRCCS Ca'Granda
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
ANTIBIOTIC PROPHYLAXIS
NO PROPHYLAXIS
Children in this arm will take antibiotic prophylaxis for 2 years. Patients in this arm will do clinical/instrumental follow-up for 5 years. The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: nitrofurantoin 1.5-2 mg/kg per day Amoxicillin-Potassium Clavulanate Combination 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) cefixime 2 mg/kg per day trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)
Children in this arm will not take antibiotic prophylaxis. Patients in this arm will do clinical/instrumental follow-up for 5 years