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临床试验/NCT02306642
NCT02306642Unknown不适用

Long Term Follow-up of Acute Kidney Injury in Very Low Birth Weight Infants

Matthew Harer, MD1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Composite Abnormality

研究概览

简要总结

The purpose of this study is to learn more about how to identify signs of early chronic kidney diseases in children who were born prematurely with low birth weight (less than 3 ½ pounds). Researchers plan to compare the kidney function in children who experienced acute kidney injury (AKI) in the Neonatal Intensive Care Unit (NICU) with those who did not experience it. Evidence from several studies and our experience at UVA show that older children who experienced AKI while in the Pediatric Intensive Care Unit (PICU) have increased risk of developing early chronic kidney disease, and they also show early changes in the urine and blood that is consistent with early chronic kidney disease. In this study, the investigators hope to determine if any of these changes can be detected in early childhood, and if so, at what age we can start detecting these changes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Premature birth for Premature groups
  • UVA NICU admission prior to 2 days of life
  • Birth weight less than 1500 grams for premature groups
  • Premature AKI Study group: Acute Kidney Injury as defined by KDIGO modified criteria during NICU stay at UVA
  • Premature no AKI Control group: No AKI during NICU stay
  • Term no AKI Control group: No AKI and born at term
  • Parental or legal guardian consent obtained

排除标准

  • Patients with Congenital Anomalies of the Kidney and Urinary Tract

结局指标

主要结局

Composite Abnormality

时间窗: Age 2-7 years

Either eGFR \> 90, urine protein/creatinine \> 0.2, or BP \> 95th percentile for age and height

次要结局

  • Growth(Age 2-6 years)
  • Kidney Size(Age 2-6 years)
  • Urinary Biomarkers(Age 2-6 years)

研究者

发起方
Matthew Harer, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthew Harer, MD

Neonatal-Perinatal Medicine Fellow, MD

University of Virginia

研究点 (1)

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