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临床试验/NCT02743273
NCT02743273已完成不适用

Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
change the level of novel urinary biomarkers after ibuprofen administration

研究概览

简要总结

Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum creatinine and a decrease in urine output. However, applying this definition to neonates remains challenging because of the normal renal physiologic features that serum creatinine levels are expected to increase in the first days after birth, and impaired sodium reabsorption and concentrating ability.

Because of several limitations of early detection of AKI, investigators are focused on identifying biomarkers that predict AKI before an increase serum creatinine level.

Investigators will collect urine from preterm infants before and after administrating ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators will analyze urine by proteomics. To verify those biomarkers, investigators will use initial urine on the first day of life from preterm infants who diagnosed AKI within 7 days after birth without any risk factors for AKI and enrolled institutional bio-repository.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants less than 32 weeks gestational age or birth weight less than 1,500 g admitted to the neonatal intensive care unit at Seoul National University Children's hospital

排除标准

  • Congenital heart disease
  • Known major congenital anomalies of the kidney and urinary tract
  • Other genetic syndromes or medical conditions that preclude enrollment per judgement of the attending neonatologist

结局指标

主要结局

change the level of novel urinary biomarkers after ibuprofen administration

时间窗: change from 1 day before ibuprofen administration to 1 day after ibuprofen administration

次要结局

  • The level of novel urinary biomarkers in initial urine(within 24 hours after birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Han-Suk Kim

Professor, Director of Neonatal Intensive Care Unit

Seoul National University Hospital

研究点 (1)

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