Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis
|ClinicalTrials.gov Identifier: NCT01330511|
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : April 7, 2011
|Condition or disease|
Patients with congenital hydronephrosis will be identified by inpatient consultations performed by Dr. Assadi for congenital hydronephrosis and by outpatient problem lists with congenital hydronephrosis of Dr. Assadi's existing patients. Once identified, the patient's grade of hydronephrosis will be recorded from initial ultrasound based on Society of Fetal Urology (SFU) classification. If no initial SFU classification was assigned to the hydronephrosis a pediatric radiologist will review the initial ultrasound images and classify the grade of hydronephrosis based upon SFU criteria. The patients ensuing evaluation of their hydronephrosis that took place will then be recorded and de-identified. Data to be collected will include: Ultrasound evaluations of the abdomen, retroperitoneum, or renal system, Voiding Cysto-Urethrogram (VCUGs), nuclear studies: diuretic enhanced technetium-99m dietylene triamine penta-acetic acid renogram (DTPA) or technetium-99m Mercapto-acetyl-triglycine renogram (MAG3), referral to pediatric urology for pyeloplasty, serum electrolytes, Blood Urea Nitrogen (BUN) and creatinine, urinalysis, urinary tract infections, and placement on long-term antibiotic prophylaxis.
The follow up evaluation that took place for each patient will then be compared to our proposed algorithm for congenital hydronephrosis evaluation and treatment. This algorithm will be designed based on clinical experience of expert opinion and literature review of each step in the evaluation and treatment. Primary outcomes will be progressive renal function decline and progression to referral to a pediatric urologist for pyeloplasty. Secondary outcomes will be incidence of urinary tract infections and placement on long term antibiotic prophylaxis for urinary tract infection prophylaxis.
|Study Type :||Observational|
|Actual Enrollment :||76 participants|
|Official Title:||Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Bilateral Hydronephrosis Grade I-II
Patients with Bilateral Hydronephrosis Grade I-II
Bil. Hydronephrosis Grade III-IV, Other
Patient with Bilateral Hydronephrosis Grade III-IV and others with any hydronephrosis and distended bladder or MCKD
Unilateral Hydronephrosis Grade I-II
Patients with Unilateral Hydronephrosis Grades I-II
Unilateral Hydronephrosis Grade III-IV
Patients with Unilateral Hydronephrosis Grade III-IV
- surgical intervention required [ Time Frame: Follow for minimum 1 year, approximately 2 years goal ]Primary outcome will be progressive renal function decline and progression to referral to a pediatric urologist for pyeloplasty.
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): NCT01330511
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Farahnak Assadi, MD||RUSH University, Pediatrics, Nephrology|