Acute Kidney InjurynNIRS-AKINCT03384173
NIRS Monitoring to Detect AKI in Preterm Infants
An observational study of Acute Kidney Injury and Premature Infant, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 7 days
- Conditions the study is for
- Acute Kidney Injury, Premature Infant
- What is being tested?
- Near Infrared Spectroscopy
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 7 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Preterm infants < 32 weeks
- Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU)
- Application of NIRS by 48 hours of age
Who cannot join
- Congenital anomaly of the kidney or urinary tract (CAKUT)
Trial locations and contacts
1 site in 1 country.
United States1 site
UnityPoint Health Meriter Hospital
Madison, Wisconsin, 53715-1507
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury, Premature Infant
- Being tested
- Near Infrared Spectroscopy
- Keywords
- Near Infrared Spectroscopy, Creatinine, Urine Output
- Medical subject headings
- Acute Kidney Injury, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared SpectroscopyDevice
Also called NIRS
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.
| Study group | Role | What they receive |
|---|---|---|
| NIRS monitoring | These infants will be monitored with NIRS Receives: Device: Near Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 week
Secondary outcomes (8)
Correlation of Renal NIRS Values to Serum Creatinine
At each time a serum creatinine was collected, the RrSO2 value was recorded.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 6 hours after caffeine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start25 Apr 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew W Harer, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384173
- Sponsor's protocol ID
- 2017-0589
- Other IDs
- 2017-013, A536757, SMPH/PEDIATRICS/PEDIATRICS
- Acronym
- nNIRS-AKI
- Status last verified
- Oct 2022
- First submitted
- 15 Dec 2017
- Last updated
- 29 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 27603562Ruf 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.
PubMed 25631390Hazle 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.
PubMed 23317940Owens 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.
PubMed 21085945McNeill 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.
PubMed 20539273
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of NIRS to Detect Acute Kidney Injury in Preterm Infants
- ClinicalTrials.gov ID
- NCT03384173
- Acronym / sponsor ID
- nNIRS-AKI / 2017-0589
- Conditions
- Acute Kidney Injury, Premature Infant
- Keywords
- Near Infrared Spectroscopy, Creatinine, Urine Output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Posted 21 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRS monitoring | – | Device: Near Infrared SpectroscopyThese infants will be monitored with NIRS |
Who may qualify
- Ages
- 1 minute to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Preterm infants < 32 weeks
- Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU)
- Application of NIRS by 48 hours of age
Key exclusion criteria (1 listed)
- Congenital anomaly of the kidney or urinary tract (CAKUT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared SpectroscopyAlso: NIRSApplication 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. | Device | NIRS monitoring |
Primary outcome
Renal NIRS Tissue Oxygenation Differential
Time frame: Up to 1 week
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.
8 secondary outcomes
Correlation of Renal NIRS Values to Serum Creatinine
Time frame: Days 1-7 of age
Correlation of Renal NIRS Values to Urine Output
Time frame: Days 1-7 of age
Baseline Renal NIRS Values Before Caffeine
Time frame: Baseline (6 hours prior to caffeine dose)
Renal NIRS Values 1 Hour After Caffeine
Time frame: At 1 hour after caffeine dose
Renal NIRS Values 2 Hours After Caffeine
Time frame: At 2 hours after caffeine dose
Renal NIRS Values 3 Hours After Caffeine
Time frame: At 3 hours after caffeine dose
Renal NIRS Values 4 Hours After Caffeine
Time frame: At 4 hours after caffeine dose
Renal NIRS Values 6 Hours After Caffeine
Time frame: At 6 hours after caffeine dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27603562Chock 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.
- Background: PubMed 25631390Ruf 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.
- Background: PubMed 23317940Hazle 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.
- Background: PubMed 21085945Owens 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.
- Background: PubMed 20539273McNeill 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew W Harer, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Premature Infant, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal NIRS Tissue Oxygenation Differential (time frame: Up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384173, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.