NIRS Monitoring to Detect AKI in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of NIRS to Detect Acute Kidney Injury in Preterm Infants

Conditions
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Acute Kidney Injury, Premature Infant

Intervention / Treatment
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* Device: Near Infrared Spectroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants < 32 weeks Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU) Application of NIRS by 48 hours of age Exclusion Criteria: Congenital anomaly of the kidney or urinary tract (CAKUT)

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NIRS monitoring<br>These infants will be monitored with NIRS | Device: Near Infrared Spectroscopy<br>* Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age.<br>* Other names: NIRS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal NIRS Tissue Oxygenation Differential | 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. | Up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Renal NIRS Values to Serum Creatinine | At each time a serum creatinine was collected, the RrSO2 value was recorded. | Days 1-7 of age | 
| Correlation of Renal NIRS Values to Urine Output | In patients with urine output recorded, it was compared to RrSO2 values | Days 1-7 of age | 
| Baseline Renal NIRS Values Before Caffeine | these are the average renal NIRS values over 6 hours prior to a dose of caffeine broken down by percentage | Baseline (6 hours prior to caffeine dose) | 
| Renal NIRS Values 1 Hour After Caffeine | Renal NIRS values one hour after caffeine broken down by baseline average. | At 1 hour after caffeine dose | 
| Renal NIRS Values 2 Hours After Caffeine | Renal NIRS values 2 hours after caffeine broken down by baseline average | At 2 hours after caffeine dose | 
| Renal NIRS Values 3 Hours After Caffeine | Renal NIRS values 3 hours after caffeine broken down by baseline average | At 3 hours after caffeine dose | 
| Renal NIRS Values 4 Hours After Caffeine | Renal NIRS values 4 hours after caffeine broken down by baseline average | At 4 hours after caffeine dose | 
| Renal NIRS Values 6 Hours After Caffeine | Renal NIRS values 6 hours after caffeine broken down by baseline average | At 6 hours after caffeine dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near Infrared Spectroscopy, Creatinine, Urine Output