Congenital HydronephrosisNCT01330511
Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis
An observational study of Congenital Hydronephrosis, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Congenital Hydronephrosis
- Type of treatment
- Injection or infusion
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants with prenatally diagnosed hydronephrosis by ultrasound who have consulted pediatric nephrology
Who may be able to join
- Inclusion criteria for the study were confirmation of the diagnosis of prenatal hydronephrosis by postnatal renal ultrasound
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Conditions
- Congenital Hydronephrosis
- Keywords
- Newborn infant, Congenital hydronephrosis, Postnatal imaging evaluation, Diagnostic algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical intervention required
Primary outcome will be progressive renal function decline and progression to referral to a pediatric urologist for pyeloplasty.
Measured: Follow for minimum 1 year, approximately 2 years goal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startJan 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Congenital HydronephrosisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Farahnak Assadi, MD, Principal investigator, RUSH University, Pediatrics, Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330511
- Sponsor's protocol ID
- 10020402
- Status last verified
- Apr 2011
- First submitted
- 1 Apr 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Warady BA, Chadha V. Chronic kidney disease in children: the global perspective. Pediatr Nephrol. 2007 Dec;22(12):1999-2009. doi: 10.1007/s00467-006-0410-1. Epub 2007 Feb 20.
PubMed 17310363Mong Hiep TT, Ismaili K, Collart F, Van Damme-Lombaerts R, Godefroid N, Ghuysen MS, Van Hoeck K, Raes A, Janssen F, Robert A. Clinical characteristics and outcomes of children with stage 3-5 chronic kidney disease. Pediatr Nephrol. 2010 May;25(5):935-40. doi: 10.1007/s00467-009-1424-2. Epub 2010 Feb 11.
PubMed 20148340Ardissino G, Dacco V, Testa S, Bonaudo R, Claris-Appiani A, Taioli E, Marra G, Edefonti A, Sereni F; ItalKid Project. Epidemiology of chronic renal failure in children: data from the ItalKid project. Pediatrics. 2003 Apr;111(4 Pt 1):e382-7. doi: 10.1542/peds.111.4.e382.
PubMed 12671156Smith JM, Stablein DM, Munoz R, Hebert D, McDonald RA. Contributions of the Transplant Registry: The 2006 Annual Report of the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS). Pediatr Transplant. 2007 Jun;11(4):366-73. doi: 10.1111/j.1399-3046.2007.00704.x.
PubMed 17493215Brown T, Mandell J, Lebowitz RL. Neonatal hydronephrosis in the era of sonography. AJR Am J Roentgenol. 1987 May;148(5):959-63. doi: 10.2214/ajr.148.5.959.
PubMed 3034009Palmer LS, Maizels M, Cartwright PC, Fernbach SK, Conway JJ. Surgery versus observation for managing obstructive grade 3 to 4 unilateral hydronephrosis: a report from the Society for Fetal Urology. J Urol. 1998 Jan;159(1):222-8. doi: 10.1016/s0022-5347(01)64072-2.
PubMed 9400485Grignon A, Filion R, Filiatrault D, Robitaille P, Homsy Y, Boutin H, Leblond R. Urinary tract dilatation in utero: classification and clinical applications. Radiology. 1986 Sep;160(3):645-7. doi: 10.1148/radiology.160.3.3526402.
PubMed 3526402Anderson N, Clautice-Engle T, Allan R, Abbott G, Wells JE. Detection of obstructive uropathy in the fetus: predictive value of sonographic measurements of renal pelvic diameter at various gestational ages. AJR Am J Roentgenol. 1995 Mar;164(3):719-23. doi: 10.2214/ajr.164.3.7863901.
PubMed 7863901Maizels M, Reisman ME, Flom LS, Nelson J, Fernbach S, Firlit CF, Conway JJ. Grading nephroureteral dilatation detected in the first year of life: correlation with obstruction. J Urol. 1992 Aug;148(2 Pt 2):609-14; discussion 615-6. doi: 10.1016/s0022-5347(17)36668-5.
PubMed 1640535Fernbach SK, Maizels M, Conway JJ. Ultrasound grading of hydronephrosis: introduction to the system used by the Society for Fetal Urology. Pediatr Radiol. 1993;23(6):478-80. doi: 10.1007/BF02012459.
PubMed 8255658Conway JJ, Maizels M. The "well tempered" diuretic renogram: a standard method to examine the asymptomatic neonate with hydronephrosis or hydroureteronephrosis. A report from combined meetings of The Society for Fetal Urology and members of The Pediatric Nuclear Medicine Council--The Society of Nuclear Medicine. J Nucl Med. 1992 Nov;33(11):2047-51.
PubMed 1432172Herndon CD, McKenna PH, Kolon TF, Gonzales ET, Baker LA, Docimo SG. A multicenter outcomes analysis of patients with neonatal reflux presenting with prenatal hydronephrosis. J Urol. 1999 Sep;162(3 Pt 2):1203-8. doi: 10.1016/S0022-5347(01)68134-5.
PubMed 10458467Ismaili K, Avni FE, Piepsz A, Wissing KM, Cochat P, Aubert D, Hall M. Current management of infants with fetal renal pelvis dilation: a survey by French-speaking pediatric nephrologists and urologists. Pediatr Nephrol. 2004 Sep;19(9):966-71. doi: 10.1007/s00467-004-1506-0. Epub 2004 Jul 6.
PubMed 15241673Lee JH, Choi HS, Kim JK, Won HS, Kim KS, Moon DH, Cho KS, Park YS. Nonrefluxing neonatal hydronephrosis and the risk of urinary tract infection. J Urol. 2008 Apr;179(4):1524-8. doi: 10.1016/j.juro.2007.11.090. Epub 2008 Mar 4.
PubMed 18295269Keays MA, Guerra LA, Mihill J, Raju G, Al-Asheeri N, Geier P, Gaboury I, Matzinger M, Pike J, Leonard MP. Reliability assessment of Society for Fetal Urology ultrasound grading system for hydronephrosis. J Urol. 2008 Oct;180(4 Suppl):1680-2; discussion1682-3. doi: 10.1016/j.juro.2008.03.107. Epub 2008 Aug 16.
PubMed 18708207
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis
- ClinicalTrials.gov ID
- NCT01330511
- Acronym / sponsor ID
- 10020402
- Conditions
- Congenital Hydronephrosis
- Keywords
- Newborn infant, Congenital hydronephrosis, Postnatal imaging evaluation, Diagnostic algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with prenatally diagnosed hydronephrosis by ultrasound who have consulted pediatric nephrology
Key inclusion criteria (1 listed)
- Inclusion criteria for the study were confirmation of the diagnosis of prenatal hydronephrosis by postnatal renal ultrasound
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
- Background: PubMed 17310363Warady BA, Chadha V. Chronic kidney disease in children: the global perspective. Pediatr Nephrol. 2007 Dec;22(12):1999-2009. doi: 10.1007/s00467-006-0410-1. Epub 2007 Feb 20.
- Background: PubMed 20148340Mong Hiep TT, Ismaili K, Collart F, Van Damme-Lombaerts R, Godefroid N, Ghuysen MS, Van Hoeck K, Raes A, Janssen F, Robert A. Clinical characteristics and outcomes of children with stage 3-5 chronic kidney disease. Pediatr Nephrol. 2010 May;25(5):935-40. doi: 10.1007/s00467-009-1424-2. Epub 2010 Feb 11.
- Background: PubMed 12671156Ardissino G, Dacco V, Testa S, Bonaudo R, Claris-Appiani A, Taioli E, Marra G, Edefonti A, Sereni F; ItalKid Project. Epidemiology of chronic renal failure in children: data from the ItalKid project. Pediatrics. 2003 Apr;111(4 Pt 1):e382-7. doi: 10.1542/peds.111.4.e382.
- Background: PubMed 17493215Smith JM, Stablein DM, Munoz R, Hebert D, McDonald RA. Contributions of the Transplant Registry: The 2006 Annual Report of the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS). Pediatr Transplant. 2007 Jun;11(4):366-73. doi: 10.1111/j.1399-3046.2007.00704.x.
- Background: PubMed 3034009Brown T, Mandell J, Lebowitz RL. Neonatal hydronephrosis in the era of sonography. AJR Am J Roentgenol. 1987 May;148(5):959-63. doi: 10.2214/ajr.148.5.959.
- Background: PubMed 9400485Palmer LS, Maizels M, Cartwright PC, Fernbach SK, Conway JJ. Surgery versus observation for managing obstructive grade 3 to 4 unilateral hydronephrosis: a report from the Society for Fetal Urology. J Urol. 1998 Jan;159(1):222-8. doi: 10.1016/s0022-5347(01)64072-2.
- Background: PubMed 3526402Grignon A, Filion R, Filiatrault D, Robitaille P, Homsy Y, Boutin H, Leblond R. Urinary tract dilatation in utero: classification and clinical applications. Radiology. 1986 Sep;160(3):645-7. doi: 10.1148/radiology.160.3.3526402.
- Background: PubMed 7863901Anderson N, Clautice-Engle T, Allan R, Abbott G, Wells JE. Detection of obstructive uropathy in the fetus: predictive value of sonographic measurements of renal pelvic diameter at various gestational ages. AJR Am J Roentgenol. 1995 Mar;164(3):719-23. doi: 10.2214/ajr.164.3.7863901.
- Background: PubMed 1640535Maizels M, Reisman ME, Flom LS, Nelson J, Fernbach S, Firlit CF, Conway JJ. Grading nephroureteral dilatation detected in the first year of life: correlation with obstruction. J Urol. 1992 Aug;148(2 Pt 2):609-14; discussion 615-6. doi: 10.1016/s0022-5347(17)36668-5.
- Background: PubMed 8255658Fernbach SK, Maizels M, Conway JJ. Ultrasound grading of hydronephrosis: introduction to the system used by the Society for Fetal Urology. Pediatr Radiol. 1993;23(6):478-80. doi: 10.1007/BF02012459.
- Background: PubMed 1432172Conway JJ, Maizels M. The "well tempered" diuretic renogram: a standard method to examine the asymptomatic neonate with hydronephrosis or hydroureteronephrosis. A report from combined meetings of The Society for Fetal Urology and members of The Pediatric Nuclear Medicine Council--The Society of Nuclear Medicine. J Nucl Med. 1992 Nov;33(11):2047-51.
- Background: PubMed 10458467Herndon CD, McKenna PH, Kolon TF, Gonzales ET, Baker LA, Docimo SG. A multicenter outcomes analysis of patients with neonatal reflux presenting with prenatal hydronephrosis. J Urol. 1999 Sep;162(3 Pt 2):1203-8. doi: 10.1016/S0022-5347(01)68134-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farahnak Assadi, MD principal investigator
RUSH University, Pediatrics, Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hydronephrosis, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical intervention required (time frame: Follow for minimum 1 year, approximately 2 years goal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01330511, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.