Trial Outcomes & Findings for NIRS Monitoring to Detect AKI in Preterm Infants (NCT NCT03384173)
NCT ID: NCT03384173
Last Updated: 2022-11-29
Results Overview
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.
COMPLETED
35 participants
Up to 1 week
2022-11-29
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NIRS Monitoring to Detect AKI in Preterm Infants
Baseline characteristics by cohort
| Measure |
No Acute Kidney Injury (AKI)
n=32 Participants
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.
|
Acute Kidney Injury (AKI)
n=3 Participants
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.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.4 gestational age (weeks)
n=5 Participants
|
25 gestational age (weeks)
n=7 Participants
|
27.2 gestational age (weeks)
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
3 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Small for gestational age
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Birth Weight
|
1135 grams
n=5 Participants
|
655 grams
n=7 Participants
|
945 grams
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 weekComparison 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.
Outcome measures
| Measure |
No Acute Kidney Injury (AKI)
n=32 Participants
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.
|
Acute Kidney Injury (AKI)
n=3 Participants
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.
|
|---|---|---|
|
Renal NIRS Tissue Oxygenation Differential
1 week Median RSO2
|
60 percentage saturation
Interval 58.4 to 62.0
|
32.4 percentage saturation
Interval 27.9 to 47.1
|
|
Renal NIRS Tissue Oxygenation Differential
Day 2 RrSO2
|
62.5 percentage saturation
Interval 59.0 to 65.7
|
44.4 percentage saturation
Interval 39.4 to 46.6
|
|
Renal NIRS Tissue Oxygenation Differential
Day 3 RrSO2
|
60.4 percentage saturation
Interval 59.3 to 61.7
|
30.8 percentage saturation
Interval 28.0 to 33.0
|
|
Renal NIRS Tissue Oxygenation Differential
Day 4 RrSO2
|
59.1 percentage saturation
Interval 57.0 to 59.9
|
29.9 percentage saturation
Interval 27.0 to 31.7
|
|
Renal NIRS Tissue Oxygenation Differential
Day 5 RrSO2
|
59.7 percentage saturation
Interval 58.4 to 61.1
|
29.2 percentage saturation
Interval 25.7 to 36.9
|
|
Renal NIRS Tissue Oxygenation Differential
Day 6 RrSO2
|
60 percentage saturation
Interval 59.0 to 61.3
|
24 percentage saturation
Interval 20.9 to 27.8
|
|
Renal NIRS Tissue Oxygenation Differential
Day 7 RrSO2
|
60.3 percentage saturation
Interval 57.8 to 66.9
|
55.3 percentage saturation
Interval 39.0 to 58.7
|
SECONDARY outcome
Timeframe: Days 1-7 of agePopulation: All participants with serum creatinine values were included
At each time a serum creatinine was collected, the RrSO2 value was recorded.
Outcome measures
| Measure |
No Acute Kidney Injury (AKI)
n=35 Participants
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.
|
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.
|
|---|---|---|
|
Correlation of Renal NIRS Values to Serum Creatinine
|
0.81 mg/dL
Interval 0.67 to 0.93
|
—
|
SECONDARY outcome
Timeframe: Days 1-7 of agePopulation: All patients
In patients with urine output recorded, it was compared to RrSO2 values
Outcome measures
| Measure |
No Acute Kidney Injury (AKI)
n=35 Participants
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.
|
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.
|
|---|---|---|
|
Correlation of Renal NIRS Values to Urine Output
|
3 mL/kg/hour
Interval 2.3 to 4.5
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 hours prior to caffeine dose)Population: 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.
these are the average renal NIRS values over 6 hours prior to a dose of caffeine broken down by percentage
Outcome measures
| Measure |
No Acute Kidney Injury (AKI)
n=156 caffeine doses
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.
|
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.
|
|---|---|---|
|
Baseline Renal NIRS Values Before Caffeine
Baseline <20% (12 caffeine doses)
|
15.24 % oxygenation
Interval 15.01 to 16.86
|
—
|
|
Baseline Renal NIRS Values Before Caffeine
Baseline 20-29.99% (16 caffeine doses)
|
26.93 % oxygenation
Interval 22.25 to 28.83
|
—
|
|
Baseline Renal NIRS Values Before Caffeine
Baseline 30-39.99% (18 caffeine doses)
|
36.11 % oxygenation
Interval 34.13 to 38.8
|
—
|
|
Baseline Renal NIRS Values Before Caffeine
Baseline 40-49.99% (13 caffeine doses)
|
48.61 % oxygenation
Interval 43.65 to 49.4
|
—
|
|
Baseline Renal NIRS Values Before Caffeine
Baseline 50-59.99% (21 caffeine doses)
|
54.41 % oxygenation
Interval 51.78 to 57.33
|
—
|
|
Baseline Renal NIRS Values Before Caffeine
Baseline >60% (76 caffeine doses)
|
73.08 % oxygenation
Interval 66.82 to 80.49
|
—
|
SECONDARY outcome
Timeframe: At 1 hour after caffeine dosePopulation: 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.
Renal NIRS values one hour after caffeine broken down by baseline average.
Outcome measures
| Measure |
No Acute Kidney Injury (AKI)
n=156 caffeine doses
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.
|
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.
|
|---|---|---|
|
Renal NIRS Values 1 Hour After Caffeine
Doses with baseline <20% (12 caffeine doses)
|
16.09 percentage saturation
Interval 15.1 to 17.45
|
—
|
|
Renal NIRS Values 1 Hour After Caffeine
Doses with baseline 20-29.99% (16 caffeine doses)
|
32.83 percentage saturation
Interval 26.38 to 38.6
|
—
|
|
Renal NIRS Values 1 Hour After Caffeine
Doses with baseline 30-39.99% (18 caffeine doses)
|
44.18 percentage saturation
Interval 34.65 to 51.26
|
—
|
|
Renal NIRS Values 1 Hour After Caffeine
Doses with baseline 40-49.99% (13 caffeine doses)
|
49.23 percentage saturation
Interval 45.71 to 55.01
|
—
|
|
Renal NIRS Values 1 Hour After Caffeine
Doses with baseline 50-59.99% (21 caffeine doses)
|
54.31 percentage saturation
Interval 51.51 to 60.61
|
—
|
|
Renal NIRS Values 1 Hour After Caffeine
Doses with baseline >60% (76 caffeine doses)
|
70.55 percentage saturation
Interval 63.44 to 77.55
|
—
|
SECONDARY outcome
Timeframe: At 2 hours after caffeine dosePopulation: 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.
Renal NIRS values 2 hours after caffeine broken down by baseline average
Outcome measures
| Measure |
No Acute Kidney Injury (AKI)
n=156 caffeine doses
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.
|
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.
|
|---|---|---|
|
Renal NIRS Values 2 Hours After Caffeine
Doses with baseline <20% (12 caffeine doses)
|
16.15 percentage saturation
Interval 15.11 to 21.61
|
—
|
|
Renal NIRS Values 2 Hours After Caffeine
Doses with baseline 20-29.99% (16 caffeine doses)
|
40.66 percentage saturation
Interval 32.83 to 47.75
|
—
|
|
Renal NIRS Values 2 Hours After Caffeine
Doses with baseline 30-39.99% (18 caffeine doses)
|
39.06 percentage saturation
Interval 26.85 to 49.9
|
—
|
|
Renal NIRS Values 2 Hours After Caffeine
Doses with baseline 40-49.99% (13 caffeine doses)
|
49.96 percentage saturation
Interval 43.6 to 56.03
|
—
|
|
Renal NIRS Values 2 Hours After Caffeine
Doses with baseline 50-59.99% (21 caffeine doses)
|
55.81 percentage saturation
Interval 49.06 to 63.2
|
—
|
|
Renal NIRS Values 2 Hours After Caffeine
Doses with baseline >60% (76 caffeine doses)
|
68.51 percentage saturation
Interval 62.63 to 78.68
|
—
|
SECONDARY outcome
Timeframe: At 3 hours after caffeine dosePopulation: 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.
Renal NIRS values 3 hours after caffeine broken down by baseline average
Outcome measures
| Measure |
No Acute Kidney Injury (AKI)
n=156 caffeine doses
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.
|
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.
|
|---|---|---|
|
Renal NIRS Values 3 Hours After Caffeine
Doses with baseline <20% (12 caffeine doses)
|
17.3 percentage saturation
Interval 16.09 to 30.97
|
—
|
|
Renal NIRS Values 3 Hours After Caffeine
Doses with baseline 20-29.99% (16 caffeine doses)
|
36.12 percentage saturation
Interval 33.25 to 41.48
|
—
|
|
Renal NIRS Values 3 Hours After Caffeine
Doses with baseline 30-39.99% (18 caffeine doses)
|
40.4 percentage saturation
Interval 30.55 to 51.71
|
—
|
|
Renal NIRS Values 3 Hours After Caffeine
Doses with baseline 40-49.99% (13 caffeine doses)
|
50.6 percentage saturation
Interval 47.21 to 54.98
|
—
|
|
Renal NIRS Values 3 Hours After Caffeine
Doses with baseline 50-59.99% (21 caffeine doses)
|
58.05 percentage saturation
Interval 53.22 to 63.53
|
—
|
|
Renal NIRS Values 3 Hours After Caffeine
Doses with baseline >60% (76 caffeine doses)
|
66.55 percentage saturation
Interval 61.92 to 74.7
|
—
|
SECONDARY outcome
Timeframe: At 4 hours after caffeine dosePopulation: 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.
Renal NIRS values 4 hours after caffeine broken down by baseline average
Outcome measures
| Measure |
No Acute Kidney Injury (AKI)
n=156 caffeine doses
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.
|
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.
|
|---|---|---|
|
Renal NIRS Values 4 Hours After Caffeine
Doses with baseline <20% (12 caffeine doses)
|
16.98 percentage saturation
Interval 15.01 to 22.93
|
—
|
|
Renal NIRS Values 4 Hours After Caffeine
Doses with baseline 20-29.99% (16 caffeine doses)
|
39.64 percentage saturation
Interval 33.55 to 48.35
|
—
|
|
Renal NIRS Values 4 Hours After Caffeine
Doses with baseline 30-39.99% (18 caffeine doses)
|
42.71 percentage saturation
Interval 29.96 to 54.29
|
—
|
|
Renal NIRS Values 4 Hours After Caffeine
Doses with baseline 40-49.99% (13 caffeine doses)
|
48.47 percentage saturation
Interval 45.52 to 53.01
|
—
|
|
Renal NIRS Values 4 Hours After Caffeine
Doses with baseline 50-59.99% (21 caffeine doses)
|
57.78 percentage saturation
Interval 52.05 to 64.33
|
—
|
|
Renal NIRS Values 4 Hours After Caffeine
Doses with baseline >60% (76 caffeine doses)
|
71.19 percentage saturation
Interval 62.12 to 79.68
|
—
|
SECONDARY outcome
Timeframe: At 6 hours after caffeine dosePopulation: 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.
Renal NIRS values 6 hours after caffeine broken down by baseline average
Outcome measures
| Measure |
No Acute Kidney Injury (AKI)
n=156 caffeine doses
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.
|
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.
|
|---|---|---|
|
Renal NIRS Values 6 Hours After Caffeine
Doses with baseline <20% (12 caffeine doses)
|
15.4 percentage saturation
Interval 15.03 to 23.82
|
—
|
|
Renal NIRS Values 6 Hours After Caffeine
Doses with baseline 20-29.99% (16 caffeine doses)
|
35.18 percentage saturation
Interval 24.22 to 43.08
|
—
|
|
Renal NIRS Values 6 Hours After Caffeine
Doses with baseline 30-39.99% (18 caffeine doses)
|
40.62 percentage saturation
Interval 33.47 to 51.59
|
—
|
|
Renal NIRS Values 6 Hours After Caffeine
Doses with baseline 40-49.99% (13 caffeine doses)
|
49.97 percentage saturation
Interval 44.94 to 57.21
|
—
|
|
Renal NIRS Values 6 Hours After Caffeine
Doses with baseline 50-59.99% (21 caffeine doses)
|
55.8 percentage saturation
Interval 43.07 to 65.74
|
—
|
|
Renal NIRS Values 6 Hours After Caffeine
Doses with baseline >60% (76 caffeine doses)
|
70.09 percentage saturation
Interval 62.65 to 79.39
|
—
|
Adverse Events
No Acute Kidney Injury (AKI)
Acute Kidney Injury (AKI)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place