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Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330511
First Posted: April 7, 2011
Last Update Posted: April 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rush University Medical Center
  Purpose
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.

Condition
Congenital Hydronephrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 76
Study Start Date: January 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants with prenatally diagnosed hydronephrosis by ultrasound who have consulted pediatric nephrology
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Farahnak Assadi, MD RUSH University, Pediatrics, Nephrology
  More Information

Publications:

Responsible Party: Farahnak Assadi, MD, RUSH University Medical Center, Pediatrics, Department of Nephrology
ClinicalTrials.gov Identifier: NCT01330511     History of Changes
Other Study ID Numbers: 10020402
First Submitted: April 1, 2011
First Posted: April 7, 2011
Last Update Posted: April 7, 2011
Last Verified: April 2011

Keywords provided by Rush University Medical Center:
Newborn infant
Congenital hydronephrosis
Postnatal imaging evaluation
Diagnostic algorithm

Additional relevant MeSH terms:
Hydronephrosis
Kidney Diseases
Urologic Diseases