NCT06731205尚未招募不适用
Long-term Renal Prognosis of Neonatal Acute Kidney Injury: A Multicenter, Prospective Cohort Study
Guangzhou Women and Children's Medical Center0 个研究点目标入组 1,852 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,852
- 主要终点
- Incidence of chronic kidney disease (CKD)
研究概览
简要总结
The goal of this observational study is to conduct a multicenter, prospective neonatal acute kidney injury (AKI) follow-up cohort to describe the clinical characteristics of chronic kidney disease (CKD) in AKI cases within 1 year of follow-up and screen for effective biomarkers that can early warn of CKD progression. Ultimately, a neonatal AKI adverse prognosis warning model based on multidimensional data will be established to provide new data and new models for CKD management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Delivered in this hospital and subsequently admitted to the NICU during the study period;
- •Diagnosed with neonatal AKI according to the 2015 KDIGO neonatal AKI criteria;
- •Age <28 days.
排除标准
- •Severe hydronephrosis diagnosed by prenatal renal ultrasound;
- •Patients with congenital urinary malformations, including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal dysplasia, and obstructive uropathy;
- •Newborns who required congenital heart surgery within the first 7 days after birth;
- •Newborns whose mothers had a history of renal failure;
- •Death within 48 hours after birth;
- •Other genetic syndromes or medical conditions were not eligible for inclusion according to the attending neonatologist's judgment.
结局指标
主要结局
Incidence of chronic kidney disease (CKD)
时间窗: 1-3 years
The incidence of CKD stage 3-5 (eGFR \< 60 ml/min) within 1, 2, and 3 years of follow-up
次要结局
- Incidence of hypertension(1-3 years)
- Mortality(1-3 years)
- Incidence of renal replacement therapy(1-3 years)
- Incidence of proteinuria(1-3 years)
- Incidence of height retardation(1-3 years)
研究者
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