N/A
N=35
NIRS Monitoring to Detect AKI in Preterm Infants
Acute Kidney Injury · Premature Infant
Bottom Line
View on ClinicalTrials.gov: NCT03384173 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Renal NIRS Tissue Oxygenation Differential — 60; 32.4; 62.5; 44.4 percentage saturation — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Near Infrared Spectroscopy (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal NIRS Tissue Oxygenation Differential |
60; 32.4; 62.5; 44.4; 60.4; 30.8 | <0.001 sig |
| SECONDARY Correlation of Renal NIRS Values to Serum Creatinine |
0.81 | 0.17 |
| SECONDARY Correlation of Renal NIRS Values to Urine Output |
3 | 0.32 |
| SECONDARY Baseline Renal NIRS Values Before Caffeine |
15.24; 26.93; 36.11; 48.61; 54.41; 73.08 | — |
| SECONDARY Renal NIRS Values 1 Hour After Caffeine |
16.09; 32.83; 44.18; 49.23; 54.31; 70.55 | <0.01 sig |
| SECONDARY Renal NIRS Values 2 Hours After Caffeine |
16.15; 40.66; 39.06; 49.96; 55.81; 68.51 | <0.001 sig |
| SECONDARY Renal NIRS Values 3 Hours After Caffeine |
17.3; 36.12; 40.4; 50.6; 58.05; 66.55 | <0.01 sig |
| SECONDARY Renal NIRS Values 4 Hours After Caffeine |
16.98; 39.64; 42.71; 48.47; 57.78; 71.19 | <0.0001 sig |
| SECONDARY Renal NIRS Values 6 Hours After Caffeine |
15.4; 35.18; 40.62; 49.97; 55.8; 70.09 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Preterm infants < 32 weeks
- Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU)
- Application of NIRS by 48 hours of age
Exclusion Criteria
- Congenital anomaly of the kidney or urinary tract (CAKUT)
Data sourced from ClinicalTrials.gov (NCT03384173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.