Near Infrared Spectroscopy (NIRS) Monitoring as an Early Predictor of Acute Kidney Injury (AKI) in a Vulnerable Neonatal Intensive Care Unit (NICU) Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Average NIRS Value (SrSO2)
研究概览
简要总结
The primary objective of this study is to describe the pattern of renal tissue oxygen saturation (SrSO2) using near-infrared spectroscopy (NIRS) in premature infants <30 weeks gestational age. The secondary objective of this study is to evaluate prenatal and postnatal risk factors for acute kidney injury (AKI) in premature infants <30 weeks gestational age. The investigators will also compare various rates of complications including death, length-of-stay, and prolonged duration of mechanical ventilation, among others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any neonate less than 30 weeks in gestational age
- •Willingness and capacity of both adult parents/guardians to sign consent
排除标准
- •An infant with known congenital anomalies of the kidney (i.e., grade 4 or 5 vesicoureteral reflux (VUR), posterior urethral valves, moderate or severe hydronephrosis, autosomal recessive polycystic kidney disease (ARPKD), bilateral renal agenesis or dysplasia)
- •Age >30 weeks gestational age
- •Age <24 weeks and <500 grams (will be excluded due to sensitivity of skin in this vulnerable population).
- •Clinician's decision that NIRS is not suitable due to the patient's clinical condition
研究组 & 干预措施
NICU patients born less than 30 weeks gestational age
All patients included in the study will be assigned to receive NIRS monitoring.
干预措施: NIRS Monitoring (Device)
结局指标
主要结局
Average NIRS Value (SrSO2)
时间窗: Up to Day-of-life 7
NIRS values measured as renal tissue oxygen saturation (SrSO2); measured continuously over first 7 days of life.
次要结局
- Duration of Mechanical Ventilation(Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations))
- Serum Creatinine Values(Day-of-life 1, Day-of-life 3, Day-of-life 7, Day-of-life 14)
- Average Urine Output(Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations))
- Length-of-Stay in NICU(Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations))
- Duration of Non-Invasive Ventilation(Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations))