Congenital HydronephrosisNCT07382570
Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months
An observational study of Congenital Hydronephrosis and UTD Grading System, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This project aims to systematically delineate the natural progression of congenital hydronephrosis diagnosed within the critical window of 0-6 months through a prospective, multicenter, observational cohort study. Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Congenital Hydronephrosis, UTD Grading System, Natural Progression
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants diagnosed with congenital hydronephrosis by abdominal ultrasound within 0-6 months after birth, meeting the UTD classification criteria (Grades I-III).
Who may be able to join
- Diagnostic Criteria: Congenital hydronephrosis is diagnosed by abdominal ultrasound examination and meets the UTD grading system criteria (Grades I-III). This is defined as an anterior-posterior renal pelvis diameter (APD) ≥4 mm during the fetal period or ≥7 mm after birth, or accompanied by calyceal dilation, renal parenchymal changes, and other manifestations.
- Informed Consent: The legal guardian voluntarily agrees to participate in the study and provides written informed consent.
- Follow-up Feasibility: The guardian commits to cooperating with the complete 3-year follow-up period, including attending regular examinations at the research center, and maintains stable contact information.
Who cannot join
- Presence of other severe congenital malformations that may affect follow-up or prognosis assessment, such as congenital heart disease, biliary atresia, spina bifida, etc.
- Secondary hydronephrosis caused by acquired factors (e.g., urinary system tumors, stones, trauma) or well-defined genetic metabolic diseases.
- Having received interventional treatments prior to enrollment, such as surgical procedures related to hydronephrosis (e.g., pyeloplasty) or pharmacological interventions (e.g., long-term use of diuretics).
- Severe underlying diseases that preclude tolerance for long-term follow-up, such as severe infections, respiratory failure, or renal failure (e.g., glomerular filtration rate < 30 ml/min/1.73m²).
- Inability of the legal guardian to cooperate due to mental illness, cognitive impairment, or refusal to comply with follow-up schedules and data collection requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Children's hospital, Zhejiang Univeristy School of Medicine
Hangzhou, Zhejiang, 310052
About this study
Official title: Multicenter Prospective Cohort Study Protocol on the Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months (3-Year Cycle)
This project aims to systematically delineate the natural progression of congenital hydronephrosis diagnosed within the critical window of 0-6 months through a prospective, multicenter, observational cohort study. The focus will be on analyzing the resolution rates, progression rates, and influencing factors of hydronephrosis of varying severities based on the UTD grading system.
Congenital hydronephrosis is one of the most common congenital urinary system abnormalities in children, with a high prenatal detection rate. However, its postnatal natural course is highly heterogeneous, leading to significant controversy in clinical management regarding follow-up intensity and intervention timing. Currently, there is a lack of prospective, large-sample, multicenter natural history data in China. By establishing a standardized follow-up system and collecting high-quality clinical and imaging data, this study aims to provide high-level evidence-based medical support for developing individualized and precise clinical management strategies, thereby reducing unnecessary interventions and delayed treatment. Consequently, conducting this multicenter study holds significant clinical and scientific value.
- Being tested
- No Intervention: Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| UTDⅠ | Not described Receives: Other: No Intervention: Observational Cohort | |
| UTD II | Not described Receives: Other: No Intervention: Observational Cohort | |
| UTD III | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydronephrosis Resolution Rate
During the follow-up period (3 years), the child's hydronephrosis decreased from the UTD grade at enrollment to grade I or below, and this status persisted for ≥6 months.
Measured: During the follow-up period (3 years)
Secondary outcomes (6)
Rate of Hydronephrosis Progression (UTD Classification)
Percentage of participants with an increase of ≥1 grade in the UTD classification compared to the baseline.
Measured: During the follow-up period (3 years)
Rate of Renal Parenchymal Thinning
Percentage of participants with a decrease of ≥2mm in renal parenchymal thickness from baseline measured by ultrasound.
Measured: During the follow-up period (3 years)
Incidence of Urinary Tract Infections (UTI)
The number of symptomatic UTI episodes per participant, characterized by a positive urine culture
Measured: During the follow-up period (3 years)
Change in Estimated Glomerular Filtration Rate (eGFR)
The mean change from baseline in eGFR levels to assess the trend of renal function over time.
Measured: During the follow-up period (3 years)
Change in Weight-for-age Z-score
The Z-scores are calculated based on the WHO Child Growth Standards to assess the child's weight development status.
Measured: During the follow-up period (3 years)
Change in Height-for-age Z-score
The Z-scores are calculated based on the WHO Child Growth Standards to assess the child's linear growth development status.
Measured: During the follow-up period (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital HydronephrosisStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe 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
- 330 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangjie Chen, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382570
- Sponsor's protocol ID
- 2026-IRB-0038-P-01
- Status last verified
- Feb 2026
- First submitted
- 10 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort Study Protocol on the Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months (3-Year Cycle)
- ClinicalTrials.gov ID
- NCT07382570
- Acronym / sponsor ID
- 2026-IRB-0038-P-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 3 Feb 2026 (actual)
- 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.
This project aims to systematically delineate the natural progression of congenital hydronephrosis diagnosed within the critical window of 0-6 months through a prospective, multicenter, observational cohort study. The focus will be on analyzing the resolution rates, progression rates, and influencing factors of hydronephrosis of varying severities based on the UTD grading system.
Congenital hydronephrosis is one of the most common congenital urinary system abnormalities in children, with a high prenatal detection rate. However, its postnatal natural course is highly heterogeneous, leading to significant controversy in clinical management regarding follow-up intensity and intervention timing. Currently, there is a lack of prospective, large-sample, multicenter natural history data in China. By establishing a standardized follow-up system and collecting high-quality clinical and imaging data, this study aims to provide high-level evidence-based medical support for developing individualized and precise clinical management strategies, thereby reducing unnecessary interventions and delayed treatment. Consequently, conducting this multicenter study holds significant clinical and scientific value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UTDⅠ | – | Other: No Intervention: Observational Cohort |
| UTD II | – | Other: No Intervention: Observational Cohort |
| UTD III | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants diagnosed with congenital hydronephrosis by abdominal ultrasound within 0-6 months after birth, meeting the UTD classification criteria (Grades I-III).
Key inclusion criteria (3 listed)
- Diagnostic Criteria: Congenital hydronephrosis is diagnosed by abdominal ultrasound examination and meets the UTD grading system criteria (Grades I-III). This is defined as an anterior-posterior renal pelvis diameter (APD) ≥4 mm during the fetal period or ≥7 mm after birth, or accompanied by calyceal dilation, renal parenchymal changes, and other manifestations.
- Informed Consent: The legal guardian voluntarily agrees to participate in the study and provides written informed consent.
- Follow-up Feasibility: The guardian commits to cooperating with the complete 3-year follow-up period, including attending regular examinations at the research center, and maintains stable contact information.
Key exclusion criteria (5 listed)
- Presence of other severe congenital malformations that may affect follow-up or prognosis assessment, such as congenital heart disease, biliary atresia, spina bifida, etc.
- Secondary hydronephrosis caused by acquired factors (e.g., urinary system tumors, stones, trauma) or well-defined genetic metabolic diseases.
- Having received interventional treatments prior to enrollment, such as surgical procedures related to hydronephrosis (e.g., pyeloplasty) or pharmacological interventions (e.g., long-term use of diuretics).
- Severe underlying diseases that preclude tolerance for long-term follow-up, such as severe infections, respiratory failure, or renal failure (e.g., glomerular filtration rate < 30 ml/min/1.73m²).
- Inability of the legal guardian to cooperate due to mental illness, cognitive impairment, or refusal to comply with follow-up schedules and data collection requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | UTD II, UTD III, UTDⅠ |
Primary outcome
Hydronephrosis Resolution Rate
Time frame: During the follow-up period (3 years)
During the follow-up period (3 years), the child's hydronephrosis decreased from the UTD grade at enrollment to grade I or below, and this status persisted for ≥6 months.
6 secondary outcomes
Rate of Hydronephrosis Progression (UTD Classification)
Time frame: During the follow-up period (3 years)
Rate of Renal Parenchymal Thinning
Time frame: During the follow-up period (3 years)
Incidence of Urinary Tract Infections (UTI)
Time frame: During the follow-up period (3 years)
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: During the follow-up period (3 years)
Change in Weight-for-age Z-score
Time frame: During the follow-up period (3 years)
Change in Height-for-age Z-score
Time frame: During the follow-up period (3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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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.
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 and UTD Grading System, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Feb 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guangjie Chen (+86 13868175229, dr.chenguangjie@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydronephrosis Resolution Rate (time frame: During the follow-up period (3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.