NIRS Monitoring to Detect AKI in Preterm Infants
- Conditions
- Acute Kidney InjuryPremature Infant
- Registration Number
- NCT03384173
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Preterm infants < 32 weeks
- Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU)
- Application of NIRS by 48 hours of age
- Congenital anomaly of the kidney or urinary tract (CAKUT)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Renal NIRS Tissue Oxygenation Differential 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.
- Secondary Outcome Measures
Name Time Method Correlation of Renal NIRS Values to Serum Creatinine Days 1-7 of age At each time a serum creatinine was collected, the RrSO2 value was recorded.
Correlation of Renal NIRS Values to Urine Output Days 1-7 of age In patients with urine output recorded, it was compared to RrSO2 values
Baseline Renal NIRS Values Before Caffeine Baseline (6 hours prior to caffeine dose) these are the average renal NIRS values over 6 hours prior to a dose of caffeine broken down by percentage
Renal NIRS Values 1 Hour After Caffeine At 1 hour after caffeine dose Renal NIRS values one hour after caffeine broken down by baseline average.
Renal NIRS Values 2 Hours After Caffeine At 2 hours after caffeine dose Renal NIRS values 2 hours after caffeine broken down by baseline average
Renal NIRS Values 3 Hours After Caffeine At 3 hours after caffeine dose Renal NIRS values 3 hours after caffeine broken down by baseline average
Renal NIRS Values 4 Hours After Caffeine At 4 hours after caffeine dose Renal NIRS values 4 hours after caffeine broken down by baseline average
Renal NIRS Values 6 Hours After Caffeine At 6 hours after caffeine dose Renal NIRS values 6 hours after caffeine broken down by baseline average
Trial Locations
- Locations (1)
UnityPoint Health Meriter Hospital
🇺🇸Madison, Wisconsin, United States
UnityPoint Health Meriter Hospital🇺🇸Madison, Wisconsin, United States