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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-013 | Other Identifier | Meriter IRB | |
| A536757 | Other Identifier | UW Madison | |
| SMPH/PEDIATRICS/PEDIATRICS | Other Identifier | UW Madison |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIRS monitoring | These infants will be monitored with NIRS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Correlation of Renal NIRS Values to Urine Output |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew W Harer, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UnityPoint Health Meriter Hospital | Madison | Wisconsin | 53715-1507 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27603562 | Background | 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. | |
| 25631390 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NIRS Monitoring | These infants will be monitored with NIRS 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Acute Kidney Injury (AKI) | Infants with No AKI diagnosis. These infants will be monitored with NIRS 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | percentage saturation | Up to 1 week |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Acute Kidney Injury (AKI) | Infants with No AKI diagnosis. These infants will be monitored with NIRS 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Harer | University of Wisconsin, Madison | 608-417-6236 | mwharer@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2017 | Sep 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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|
In patients with urine output recorded, it was compared to RrSO2 values
| 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 | 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. | 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 | 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 | 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 | 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 | At 6 hours after caffeine dose |
| 23317940 | 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. |
| 21085945 | 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. |
| 20539273 | 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. |
| Acute Kidney Injury (AKI) |
Infants diagnosed with AKI. These infants will be monitored with NIRS 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. |
| BG002 | Total | Total of all reporting groups |
| gestational age (weeks) |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Small for gestational age | Small for gestational age defined as <10% for birthweight on the Fenton Growth Chart. | Number | participants |
|
| Birth Weight | Median | Inter-Quartile Range | grams |
|
Infants diagnosed with AKI. These infants will be monitored with NIRS 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. |
|
|
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| Secondary | Correlation of Renal NIRS Values to Serum Creatinine | At each time a serum creatinine was collected, the RrSO2 value was recorded. | All participants with serum creatinine values were included | Posted | Median | Inter-Quartile Range | mg/dL | 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 | All patients | Posted | Median | Inter-Quartile Range | mL/kg/hour | Days 1-7 of age |
|
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|
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| 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 | Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician. This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage. The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data. | Posted | Median | Inter-Quartile Range | % oxygenation | Baseline (6 hours prior to caffeine dose) | caffeine doses | caffeine doses |
|
|
|
| Secondary | Renal NIRS Values 1 Hour After Caffeine | Renal NIRS values one hour after caffeine broken down by baseline average. | Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician. This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage. The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data. | Posted | Median | Inter-Quartile Range | percentage saturation | At 1 hour after caffeine dose | caffeine doses | caffeine doses |
|
|
|
|
| Secondary | Renal NIRS Values 2 Hours After Caffeine | Renal NIRS values 2 hours after caffeine broken down by baseline average | Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician. This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage. The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data. | Posted | Median | Inter-Quartile Range | percentage saturation | At 2 hours after caffeine dose | caffeine doses | caffeine doses |
|
|
|
|
| Secondary | Renal NIRS Values 3 Hours After Caffeine | Renal NIRS values 3 hours after caffeine broken down by baseline average | Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician. This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage. The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data. | Posted | Median | Inter-Quartile Range | percentage saturation | At 3 hours after caffeine dose | caffeine doses | caffeine doses |
|
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|
| Secondary | Renal NIRS Values 4 Hours After Caffeine | Renal NIRS values 4 hours after caffeine broken down by baseline average | Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician. This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage. The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data. | Posted | Median | Inter-Quartile Range | percentage saturation | At 4 hours after caffeine dose | caffeine doses | caffeine doses |
|
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|
| Secondary | Renal NIRS Values 6 Hours After Caffeine | Renal NIRS values 6 hours after caffeine broken down by baseline average | Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician. This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage. The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data. | Posted | Median | Inter-Quartile Range | percentage saturation | At 6 hours after caffeine dose | caffeine doses | caffeine doses |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Acute Kidney Injury (AKI) | Infants diagnosed with AKI. These infants will be monitored with NIRS 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| Baseline 20-29.99% (16 caffeine doses) |
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| Baseline 30-39.99% (18 caffeine doses) |
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| Baseline 40-49.99% (13 caffeine doses) |
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| Baseline 50-59.99% (21 caffeine doses) |
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| Baseline >60% (76 caffeine doses) |
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| Doses with baseline 20-29.99% (16 caffeine doses) |
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| Doses with baseline 30-39.99% (18 caffeine doses) |
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| Doses with baseline 40-49.99% (13 caffeine doses) |
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| Doses with baseline 50-59.99% (21 caffeine doses) |
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| Doses with baseline >60% (76 caffeine doses) |
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| Doses with baseline 20-29.99% (16 caffeine doses) |
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| Doses with baseline 30-39.99% (18 caffeine doses) |
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| Doses with baseline 40-49.99% (13 caffeine doses) |
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| Doses with baseline 50-59.99% (21 caffeine doses) |
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| Doses with baseline >60% (76 caffeine doses) |
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| Doses with baseline 20-29.99% (16 caffeine doses) |
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| Doses with baseline 30-39.99% (18 caffeine doses) |
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| Doses with baseline 40-49.99% (13 caffeine doses) |
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| Doses with baseline 50-59.99% (21 caffeine doses) |
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| Doses with baseline >60% (76 caffeine doses) |
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| Doses with baseline 20-29.99% (16 caffeine doses) |
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| Doses with baseline 30-39.99% (18 caffeine doses) |
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| Doses with baseline 40-49.99% (13 caffeine doses) |
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| Doses with baseline 50-59.99% (21 caffeine doses) |
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| Doses with baseline >60% (76 caffeine doses) |
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| Doses with baseline 20-29.99% (16 caffeine doses) |
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| Doses with baseline 30-39.99% (18 caffeine doses) |
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| Doses with baseline 40-49.99% (13 caffeine doses) |
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| Doses with baseline 50-59.99% (21 caffeine doses) |
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| Doses with baseline >60% (76 caffeine doses) |
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