Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,186
- 试验地点
- 1
- 主要终点
- Define the major risk factors associated with neonatal AKI. We will randomly split the cohort into two groups. We will develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group.
研究概览
简要总结
Introduction:
Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized the need to improve collaborations between neonatologists and nephrologists within and across centers. The investigators have created a multi-institutional, multi-disciplinary group, Neonatal Kidney Collaborative (NKC), in order to address the following critical needs identified at the workshop: AWAKEN is the inaugural study of this new collaboration.
- Development of a standardized evidence-based definition of neonatal AKI
- Evaluation of risk factors that predispose neonatal to AKI
- Investigation into how fluid provision/ balance impacts biochemical and clinical outcomes
详细描述
The investigators will conduct a multi-center retrospective cohort study. The investigators will enroll eligible infants who meet inclusion and exclusion criteria at each center for 3 consecutive months. Based on average admissions for 2013 at our centers who meet inclusion and exclusion criteria, and estimate that it can enroll approximately 3000 infants during this time.
A. Specific Aim 1: Determine if the proposed neonatal AKI definition adapted to neonates is able to predict mortality, length of stay, and discharge serum creatinine (SCr).
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Our primary hypothesis is that higher stages of AKI are associated with mortality, even after controlling for severity of illness, interventions and demographics.
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Populations
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Inclusion Criteria - All infants born or admitted to a level 2 or 3 NICU will be screened. Infants who received intravenous fluids for > 48 hours will be eligible.
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Exclusion -- Infants admitted to the NICU at 2 weeks of age or older; Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life; Infants diagnosed with a lethal anomaly upon admission; Infants who die within 48 hours after birth
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Primary Exposure - Neonatal AKI definitions (table 3)
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Primary Outcome - Survival
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In premature infants - defined as survival to 36 weeks post gestational age or hospital discharge (whichever comes first)
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In term infants - defined as hospital survival to 28 days.
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Secondary outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Minute 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants born or admitted to a level 2 or 3 NICU will be screened.
- •Infants who received intravenous fluids for > 48 hours will be eligible.
排除标准
- •Infants admitted to the NICU at 2 weeks of age or older
- •Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life
- •Infants diagnosed with a lethal anomaly upon admission
- •Infants who die within 48 hours after birth
结局指标
主要结局
Define the major risk factors associated with neonatal AKI. We will randomly split the cohort into two groups. We will develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group.
时间窗: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
Determine if the KDIGO AKI definition adapted to neonates can predict mortality, length of stay, and discharge serum creatinine (SCr).
时间窗: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
Determine how fluid balance during the first few weeks of life relates to biochemical data and clinical outcomes.
时间窗: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
次要结局
未报告次要终点
研究者
David Askenazi
MD, MsPH, Associate Professor
University of Alabama at Birmingham