Меню
Набор скоро начнётся NCT07382570

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

— Наблюдательное Congenital Hydronephrosis UTD Grading System Natural Progression Pediatric

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No Intervention: Observational Cohort.
Кому может быть актуально
Состояния в реестре: Congenital Hydronephrosis, UTD Grading System, Natural Progression, Pediatric. Базовые параметры: 0 мес. — 6 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Вмешательства

  • Другое No Intervention: Observational Cohort
    No intervention

Первичные конечные точки

  • Hydronephrosis Resolution Rate [Срок оценки: During the follow-up period (3 years)]
Вторичные конечные точки (6)
  • Rate of Hydronephrosis Progression (UTD Classification) [Срок оценки: During the follow-up period (3 years)]
  • Rate of Renal Parenchymal Thinning [Срок оценки: During the follow-up period (3 years)]
  • Incidence of Urinary Tract Infections (UTI) [Срок оценки: During the follow-up period (3 years)]
  • Change in Estimated Glomerular Filtration Rate (eGFR) [Срок оценки: During the follow-up period (3 years)]
  • Change in Weight-for-age Z-score [Срок оценки: During the follow-up period (3 years)]
  • Change in Height-for-age Z-score [Срок оценки: During the follow-up period (3 years)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Children's hospital, Zhejiang Univeristy School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07382570 · 2026-IRB-0038-P-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗