NIRS Monitoring to Detect AKI in Preterm Infants (nNIRS-AKI)

Use of NIRS to Detect Acute Kidney Injury in Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Premature Infant
• Intervention / Treatment: Device: Near Infrared Spectroscopy

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715-1507
      • UnityPoint Health Meriter Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants that are less than 32 weeks, admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU) with application of NIRS by 48 hours of age.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NIRS monitoring; These infants will be monitored with NIRS	Device: Near Infrared Spectroscopy; 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.; Other Names: NIRS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Matthew W Harer, MD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• Chock VY, Rose LA, Mante JV, Punn R. Near-infrared spectroscopy for detection of a significant patent ductus arteriosus. Pediatr Res. 2016 Nov;80(5):675-680. doi: 10.1038/pr.2016.148. Epub 2016 Sep 7.
• Ruf B, Bonelli V, Balling G, Horer J, Nagdyman N, Braun SL, Ewert P, Reiter K. Intraoperative renal near-infrared spectroscopy indicates developing acute kidney injury in infants undergoing cardiac surgery with cardiopulmonary bypass: a case-control study. Crit Care. 2015 Jan 29;19(1):27. doi: 10.1186/s13054-015-0760-9.
• Hazle MA, Gajarski RJ, Aiyagari R, Yu S, Abraham A, Donohue J, Blatt NB. Urinary biomarkers and renal near-infrared spectroscopy predict intensive care unit outcomes after cardiac surgery in infants younger than 6 months of age. J Thorac Cardiovasc Surg. 2013 Oct;146(4):861-867.e1. doi: 10.1016/j.jtcvs.2012.12.012. Epub 2013 Jan 12.
• Owens GE, King K, Gurney JG, Charpie JR. Low renal oximetry correlates with acute kidney injury after infant cardiac surgery. Pediatr Cardiol. 2011 Feb;32(2):183-8. doi: 10.1007/s00246-010-9839-x. Epub 2010 Nov 19.
• McNeill S, Gatenby JC, McElroy S, Engelhardt B. Normal cerebral, renal and abdominal regional oxygen saturations using near-infrared spectroscopy in preterm infants. J Perinatol. 2011 Jan;31(1):51-7. doi: 10.1038/jp.2010.71. Epub 2010 Jun 10.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Near Infrared Spectroscopy; Creatinine; Urine Output
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 2017-0589; 2017-013 (Other Identifier: Meriter IRB); A536757 (Other Identifier: UW- Madison); SMPH/PEDIATRICS/PEDIATRICS (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes