Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07382570

Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

0 month–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's hospital, Zhejiang Univeristy School of Medicine

Hangzhou, Zhejiang, 310052, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of Hydronephrosis Progression (UTD Classification)

    Time frame: During the follow-up period (3 years)

    Percentage of participants with an increase of ≥1 grade in the UTD classification compared to the baseline.

  2. Rate of Renal Parenchymal Thinning

    Time frame: During the follow-up period (3 years)

    Percentage of participants with a decrease of ≥2mm in renal parenchymal thickness from baseline measured by ultrasound.

  3. Incidence of Urinary Tract Infections (UTI)

    Time frame: During the follow-up period (3 years)

    The number of symptomatic UTI episodes per participant, characterized by a positive urine culture

  4. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: During the follow-up period (3 years)

    The mean change from baseline in eGFR levels to assess the trend of renal function over time.

  5. Change in Weight-for-age Z-score

    Time frame: During the follow-up period (3 years)

    The Z-scores are calculated based on the WHO Child Growth Standards to assess the child's weight development status.

  6. Change in Height-for-age Z-score

    Time frame: During the follow-up period (3 years)

    The Z-scores are calculated based on the WHO Child Growth Standards to assess the child's linear growth development status.

Study contacts

Contact information is provided by the study sponsor or research team.

Guangjie Chen

CONTACT

[email protected]

+86 13868175229

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

Multicenter Prospective Cohort Study Protocol on the Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months (3-Year Cycle)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 3, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.