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NIRS for AKI in Preterm Infants (nNIRS-AKI)

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ClinicalTrials.gov Identifier: NCT03384173
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This study will examine the relationship of oxygen levels, using 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Premature Infant Device: Near Infrared Spectroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of NIRS to Detect Acute Kidney Injury in Preterm Infants
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Arm Intervention/treatment
Experimental: 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 Name: NIRS




Primary Outcome Measures :
  1. Renal NIRS tissue oxygenation differential [ Time Frame: Days 1-7 of age ]
    Comparison of Renal saturation (Rsat) in patients with AKI to those without AKI.


Secondary Outcome Measures :
  1. Correlation of renal NIRS values to serum creatinine and urine output [ Time Frame: Days 1-7 of age ]
    In patients with AKI, renal NIRS values (Rsat) will be correlated with changes in serum creatinine and urine output.

  2. Effect of neonatal medications on renal NIRS values [ Time Frame: Days 1-7 of age ]
    Renal saturation values following administration of neonatal medications will be compared to mean renal saturation values for each specific patient.



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants < 32 weeks
  • Admitted to UPH Meriter NICU
  • Application of NIRS by 48 hours of age

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384173


Contacts
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Contact: Matthew Harer, MD 608-417-6236 mwharer@wisc.edu
Contact: Ryan McAdams, MD 608-417-6236

Locations
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United States, Wisconsin
UnityPoint Health Meriter Hospital Recruiting
Madison, Wisconsin, United States, 53715-1507
Contact: Matthew Harer, MD       mwharer@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison

Publications of Results:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03384173     History of Changes
Other Study ID Numbers: 2017-0589
207-013 ( Other Identifier: Meriter IRB )
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by University of Wisconsin, Madison:
Near Infrared Spectroscopy
Creatinine
Urine Output

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases