Major study to watch kidney swelling in infants – no treatment, just observation
NCT ID NCT07382570
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will follow 330 infants diagnosed with congenital hydronephrosis (kidney swelling) between birth and 6 months of age for three years. Researchers will track whether the condition gets better, stays the same, or worsens using ultrasound scans. The goal is to understand the natural course of the disease so doctors can make better decisions about when to intervene or simply monitor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better guidelines for when to treat or wait in infants with congenital hydronephrosis, reducing unnecessary surgeries and preventing kidney damage.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly test any therapy. Results may take years and might not change practice if the natural course varies widely.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 330 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Infants diagnosed with congenital hydronephrosis by abdominal ultrasound within 0-6 months after birth, meeting the UTD classification criteria (Grades I-III).
- Ages
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0 to 6 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's hospital, Zhejiang Univeristy School of Medicine
Hangzhou, Zhejiang, 310052, China
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