Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis

This study has been completed.
Sponsor:
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01330511
First received: April 1, 2011
Last updated: April 5, 2011
Last verified: April 2011

April 1, 2011
April 5, 2011
January 2005
January 2010   (final data collection date for primary outcome measure)
surgical intervention required [ Time Frame: Follow for minimum 1 year, approximately 2 years goal ] [ Designated as safety issue: No ]
Primary outcome will be progressive renal function decline and progression to referral to a pediatric urologist for pyeloplasty.
Same as current
Complete list of historical versions of study NCT01330511 on ClinicalTrials.gov Archive Site
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Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis
Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis

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. Given standard evaluation will be evaluated to determine if based on initial ultrasound classification an algorithm can be developed to target evaluation studies for the initial evaluation. With a goal of targeting the few children that have need of additional intervention and minimizing the studies performed on children who will spontaneously resolve.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Infants with prenatally diagnosed hydronephrosis by ultrasound who have consulted pediatric nephrology

Congenital Hydronephrosis
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  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Inclusion criteria for the study were confirmation of the diagnosis of prenatal hydronephrosis by postnatal renal ultrasound

Exclusion Criteria:

  • prior history of UTI
  • diagnosis of cystic renal dysplasia with poorly functioning kidney
  • previous operation on the urinary tract system
  • and other deformities of the external genital organs or anomalies in cardiopulmonary and central nervous system
Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01330511
10020402
No
Farahnak Assadi, MD, RUSH University Medical Center, Pediatrics, Department of Nephrology
Rush University Medical Center
Not Provided
Principal Investigator: Farahnak Assadi, MD RUSH University, Pediatrics, Nephrology
Rush University Medical Center
April 2011

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