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临床试验/NCT00573079
NCT00573079已完成不适用

Acute Kidney Injury in Premature Infants

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2007年12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
237
试验地点
1
主要终点
Characterize the incidence and risk factors in critically ill premature infants

研究概览

简要总结

Our first Aim is to describe how common a sudden decrease in renal function happens in premature infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal function affects survival. Finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples.

详细描述

Advancements in the field of peri-natal medicine has improved the survival of critically ill neonates but yet many still do not survive, and many more are left with long-term damage to vital organ systems. Very little data is available on the impact that acute kidney injury (AKI) has on survival in premature infants, but adult and pediatric studies that show that even mild AKI independently impacts survival after correcting for severity of illness. The role that AKI impacts survival in premature infants is likely to be greater than adults as this acute injury occurs in context of impaired and ongoing kidney development..

Our ability to improve outcomes in children and adults with AKI has been hampered by the inability to recognize AKI early in the disease process. Thus, the work on early non-invasive biomarkers of renal injury has brought great optimism to the field of AKI. Serum and urinary levels of neutrophil gelatinase-associated lipocalin (NGAL), urinary interleukin 18 (IL-18) others are markedly elevated several hours after AKI as opposed to serum creatinine which takes days to rise after the inciting event. Early non-invasive biomarkers of AKI have not been tested in premature infants.

Inclusion criteria - infants (birthweight 500-1500g) be asked to participate in the study. • Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Minute 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 500-1500 grams birthweight
  • >=25 weeks gestation

排除标准

  • infants who do not survive 24 hours of life
  • infants with severe congenital abnormalities

结局指标

主要结局

Characterize the incidence and risk factors in critically ill premature infants

时间窗: 2 years

次要结局

  • Compare hospital of premature infants outcomes with and without AKI. Test ability of known noninvasive urinary biomarkers' ability to detect AKI in premature infants(2 years)

研究者

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

David Askenazi

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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