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临床试验/NCT03384173
NCT03384173已完成不适用

Use of NIRS to Detect Acute Kidney Injury in Preterm Infants

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Renal NIRS Tissue Oxygenation Differential

研究概览

简要总结

This study will examine the relationship of oxygen levels, using Near-infrared spectroscopy (NIRS) monitoring, and kidney injury in infants born prematurely. NIRS is a skin sensor which detects the amount of oxygen going to different organs, most often used to monitor the brain and kidney.

详细描述

This prospective, single-center study was conducted at UnityPoint Health-Meriter Hospital (Madison, WI, USA) in preterm neonates admitted to a level III NICU from April 2018 to August 2019. The primary study aim was to assess changes in RrSO2 with continuous renal NIRS monitoring to detect AKI during the first 7 days of age.

The INVOS 5100 C (Somanetics, Troy, MI, USA) four channel NIRS monitors were used to measure RrSO2 (measured at the right or left flank) and Cerebral regional Somatic tissue Oxygenation (CrSO2; measured at the forehead) for all neonates. At each measurement site, for skin protection, subjects had a transparent Mepitel (with Safetac Technology, Norcross, GA) adhesive dressing placed with the adhesive neonatal NIRS sensor (INVOS OxyAlert NIRSensor, Covidien) adhered over the Mepitel dressing. Neither cerebral or kidney sensors were placed with ultrasound guidance. Tissue oxygenation was recorded every 3 seconds until 7 days of age, and the sensor was changed one time when the patient reached three to four days of age per the company's recommendation. There were no restrictions on positioning or handling of neonates; nurses re-positioned neonates every 3-6 hours per unit protocol to prevent skin pressure injuries. Researchers, staff, and parents were blinded to RrSO2 values.

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
1 Minute 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants < 32 weeks
  • Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU)
  • Application of NIRS by 48 hours of age

排除标准

  • Congenital anomaly of the kidney or urinary tract (CAKUT)

结局指标

主要结局

Renal NIRS Tissue Oxygenation Differential

时间窗: Up to 1 week

Comparison of Renal saturation (Rsat) in neonates with AKI to those without AKI. RSO2 will be recorded until 7 days of age. Median RSO2 for 1 week and median for individual days 2-7 will be calculated. The INVOS 5100 C (Somanetics, Troy, MI, USA) four channel NIRS monitors will be used to measure renal regional oxygenation (RrSO2) values for all neonates.

次要结局

  • Correlation of Renal NIRS Values to Serum Creatinine(Days 1-7 of age)
  • Correlation of Renal NIRS Values to Urine Output(Days 1-7 of age)
  • Baseline Renal NIRS Values Before Caffeine(Baseline (6 hours prior to caffeine dose))
  • Renal NIRS Values 1 Hour After Caffeine(At 1 hour after caffeine dose)
  • Renal NIRS Values 2 Hours After Caffeine(At 2 hours after caffeine dose)
  • Renal NIRS Values 3 Hours After Caffeine(At 3 hours after caffeine dose)
  • Renal NIRS Values 4 Hours After Caffeine(At 4 hours after caffeine dose)
  • Renal NIRS Values 6 Hours After Caffeine(At 6 hours after caffeine dose)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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