NIRS Monitoring to Detect AKI in Preterm Infants

NCT03384173 | Completed Results FDA Device

• 4 other identifiers: 2017-05892017-013A536757SMPH/PEDIATRICS/PEDIATRICS
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Premature Infant

Keywords

Near Infrared Spectroscopy; Creatinine; Urine Output

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Correlation of Renal NIRS Values to Serum Creatinine

  Days 1-7 of age

• Correlation of Renal NIRS Values to Urine Output

  Days 1-7 of age

• Baseline Renal NIRS Values Before Caffeine

  Baseline (6 hours prior to caffeine dose)

• Renal NIRS Values 1 Hour After Caffeine

  At 1 hour after caffeine dose

• Renal NIRS Values 2 Hours After Caffeine

  At 2 hours after caffeine dose

Study Arms (1)

NIRS monitoring

These infants will be monitored with NIRS

Device: Near Infrared Spectroscopy

Interventions

Near Infrared Spectroscopy DEVICE

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.

Also known as: NIRS

NIRS monitoring

Eligibility Criteria

• Age: 1 Minute - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Preterm infants \< 32 weeks
• Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU)
• Application of NIRS by 48 hours of age

You may not qualify if:

• Congenital anomaly of the kidney or urinary tract (CAKUT)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UnityPoint Health Meriter Hospital

Madison, Wisconsin, 53715-1507, United States

Location

Related 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.

  PMID: 27603562 BACKGROUND

• 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.

  PMID: 25631390 BACKGROUND

• 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.

  PMID: 23317940 BACKGROUND

• 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.

  PMID: 21085945 BACKGROUND

• 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.

  PMID: 20539273 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Premature Birth

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Matthew Harer
• Organization: University of Wisconsin, Madison

mwharer@wisc.edu

608-417-6236

Study Officials

• Matthew W Harer, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 27, 2017
• Study Start: April 25, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 29, 2022
• Results First Posted: December 21, 2020

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)