NIRS Monitoring to Detect AKI in Preterm Infants

Acute Kidney Injury Clinical Trial

— nNIRS-AKI  

Official title:

Use of NIRS to Detect Acute Kidney Injury in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384173
• Other study ID #: 2017-0589
• Secondary ID: 2017-013A536757S
• Status: Completed
• Start date: April 25, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 7 Days

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Premature Infant

Intervention

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.

Locations

Country	Name	City	State
United States	UnityPoint Health Meriter Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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