Clinical trial NCT03384173: NIRS Monitoring to Detect AKI in Preterm Infants
Official title: Use of NIRS to Detect Acute Kidney Injury in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Premature Infant
Keywords: Near Infrared Spectroscopy
Creatinine
Urine Output
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Renal NIRS Tissue Oxygenation Differential
timeFrame: Up to 1 week
Secondary outcomes:
measure: Correlation of Renal NIRS Values to Serum Creatinine
timeFrame: Days 1-7 of age
measure: Correlation of Renal NIRS Values to Urine Output
timeFrame: Days 1-7 of age
measure: Baseline Renal NIRS Values Before Caffeine
timeFrame: Baseline (6 hours prior to caffeine dose)
measure: Renal NIRS Values 1 Hour After Caffeine
timeFrame: At 1 hour after caffeine dose
measure: Renal NIRS Values 2 Hours After Caffeine
timeFrame: At 2 hours after caffeine dose
measure: Renal NIRS Values 3 Hours After Caffeine
timeFrame: At 3 hours after caffeine dose
measure: Renal NIRS Values 4 Hours After Caffeine
timeFrame: At 4 hours after caffeine dose
measure: Renal NIRS Values 6 Hours After Caffeine
timeFrame: At 6 hours after caffeine dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: UnityPoint Health Meriter Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Matthew W Harer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.