Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis

Brief Title

Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis

Official Title

Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis

Brief Summary

      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.
    

Detailed Description

      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


Primary Outcome

surgical intervention required


Condition

Congenital Hydronephrosis


Study Arms / Comparison Groups

 Bilateral Hydronephrosis Grade I-II
Description:  Patients with Bilateral Hydronephrosis Grade I-II

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

76

Start Date

January 2005

Completion Date

January 2010

Primary Completion Date

January 2010

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 2 Years

Accepts Healthy Volunteers

No

Contacts

Farahnak Assadi, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01330511

Organization ID

10020402



Study Sponsor

Rush University Medical Center


Study Sponsor

Farahnak Assadi, MD, Principal Investigator, RUSH University, Pediatrics, Nephrology


Verification Date

April 2011