Who is sponsoring NCT03384173?

NCT03384173 is sponsored by University of Wisconsin, Madison.

What drugs are being tested in NCT03384173?

Interventions in NCT03384173: Near Infrared Spectroscopy.

What condition does NCT03384173 study?

NCT03384173 studies Acute Kidney Injury, Premature Infant.

Is NCT03384173 still recruiting?

NCT03384173 is currently completed. Last updated 29 November 2022.

Are results published for NCT03384173?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-29 · How we verify

NCT03384173: nNIRS-AKI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

NIRS Monitoring to Detect AKI in Preterm Infants

Completed Results posted Last updated 29 November 2022

What this trial tests

trial testing Near Infrared Spectroscopy in Acute Kidney Injury in 35 participants. Completed in 31 December 2019.

Timeline

25 April 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	University of Wisconsin, Madison
Status	Completed
Study type	OBSERVATIONAL
Enrollment	35
Start date	25 April 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

Near Infrared Spectroscopy

Conditions studied

Acute Kidney Injury — all drugs for Acute Kidney Injury →
Premature Infant — all drugs for Premature Infant →

Sponsor

University of Wisconsin, Madison

Who can join

Adults 1 Minute to 7 Days, any sex, with Acute Kidney Injury or Premature Infant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Renal NIRS Tissue Oxygenation Differential Primary · 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.

1 week Median RSO2

Group	Value	95% CI
No Acute Kidney Injury (AKI)	60	58.4 – 62
Acute Kidney Injury (AKI)	32.4	27.9 – 47.1

Day 2 RrSO2

Group	Value	95% CI
No Acute Kidney Injury (AKI)	62.5	59 – 65.7
Acute Kidney Injury (AKI)	44.4	39.4 – 46.6

Day 3 RrSO2

Group	Value	95% CI
No Acute Kidney Injury (AKI)	60.4	59.3 – 61.7
Acute Kidney Injury (AKI)	30.8	28 – 33

Day 4 RrSO2

Group	Value	95% CI
No Acute Kidney Injury (AKI)	59.1	57 – 59.9
Acute Kidney Injury (AKI)	29.9	27 – 31.7

Day 5 RrSO2

Group	Value	95% CI
No Acute Kidney Injury (AKI)	59.7	58.4 – 61.1
Acute Kidney Injury (AKI)	29.2	25.7 – 36.9

Day 6 RrSO2

Group	Value	95% CI
No Acute Kidney Injury (AKI)	60	59 – 61.3
Acute Kidney Injury (AKI)	24	20.9 – 27.8

Day 7 RrSO2

Group	Value	95% CI
No Acute Kidney Injury (AKI)	60.3	57.8 – 66.9
Acute Kidney Injury (AKI)	55.3	39 – 58.7

Correlation of Renal NIRS Values to Serum Creatinine Secondary · Days 1-7 of age

At each time a serum creatinine was collected, the RrSO2 value was recorded.

Group	Value	95% CI
Infants With Serum Creatinine Values	0.81	0.67 – 0.93

Correlation of Renal NIRS Values to Urine Output Secondary · Days 1-7 of age

In patients with urine output recorded, it was compared to RrSO2 values

Group	Value	95% CI
Neonates With Urine Output Recorded	3	2.3 – 4.5

Baseline Renal NIRS Values Before Caffeine Secondary · Baseline (6 hours prior to caffeine dose)

these are the average renal NIRS values over 6 hours prior to a dose of caffeine broken down by percentage

Baseline <20% (12 caffeine doses)

Group	Value	95% CI
Baseline Renal NIRS Values Before Caffeine	15.24	15.01 – 16.86

Baseline 20-29.99% (16 caffeine doses)

Group	Value	95% CI
Baseline Renal NIRS Values Before Caffeine	26.93	22.25 – 28.83

Baseline 30-39.99% (18 caffeine doses)

Group	Value	95% CI
Baseline Renal NIRS Values Before Caffeine	36.11	34.13 – 38.8

Baseline 40-49.99% (13 caffeine doses)

Group	Value	95% CI
Baseline Renal NIRS Values Before Caffeine	48.61	43.65 – 49.4

Baseline 50-59.99% (21 caffeine doses)

Group	Value	95% CI
Baseline Renal NIRS Values Before Caffeine	54.41	51.78 – 57.33

Baseline >60% (76 caffeine doses)

Group	Value	95% CI
Baseline Renal NIRS Values Before Caffeine	73.08	66.82 – 80.49

Renal NIRS Values 1 Hour After Caffeine Secondary · At 1 hour after caffeine dose

Renal NIRS values one hour after caffeine broken down by baseline average.

Doses with baseline <20% (12 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	16.09	15.1 – 17.45

Doses with baseline 20-29.99% (16 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	32.83	26.38 – 38.6

Doses with baseline 30-39.99% (18 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	44.18	34.65 – 51.26

Doses with baseline 40-49.99% (13 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	49.23	45.71 – 55.01

Doses with baseline 50-59.99% (21 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	54.31	51.51 – 60.61

Doses with baseline >60% (76 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	70.55	63.44 – 77.55

Renal NIRS Values 2 Hours After Caffeine Secondary · At 2 hours after caffeine dose

Renal NIRS values 2 hours after caffeine broken down by baseline average

Doses with baseline <20% (12 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	16.15	15.11 – 21.61

Doses with baseline 20-29.99% (16 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	40.66	32.83 – 47.75

Doses with baseline 30-39.99% (18 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	39.06	26.85 – 49.9

Doses with baseline 40-49.99% (13 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	49.96	43.6 – 56.03

Doses with baseline 50-59.99% (21 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	55.81	49.06 – 63.2

Doses with baseline >60% (76 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	68.51	62.63 – 78.68

Renal NIRS Values 3 Hours After Caffeine Secondary · At 3 hours after caffeine dose

Renal NIRS values 3 hours after caffeine broken down by baseline average

Doses with baseline <20% (12 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	17.3	16.09 – 30.97

Doses with baseline 20-29.99% (16 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	36.12	33.25 – 41.48

Doses with baseline 30-39.99% (18 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	40.4	30.55 – 51.71

Doses with baseline 40-49.99% (13 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	50.6	47.21 – 54.98

Doses with baseline 50-59.99% (21 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	58.05	53.22 – 63.53

Doses with baseline >60% (76 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	66.55	61.92 – 74.7

Renal NIRS Values 4 Hours After Caffeine Secondary · At 4 hours after caffeine dose

Renal NIRS values 4 hours after caffeine broken down by baseline average

Doses with baseline <20% (12 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	16.98	15.01 – 22.93

Doses with baseline 20-29.99% (16 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	39.64	33.55 – 48.35

Doses with baseline 30-39.99% (18 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	42.71	29.96 – 54.29

Doses with baseline 40-49.99% (13 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	48.47	45.52 – 53.01

Doses with baseline 50-59.99% (21 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	57.78	52.05 – 64.33

Doses with baseline >60% (76 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	71.19	62.12 – 79.68

Renal NIRS Values 6 Hours After Caffeine Secondary · At 6 hours after caffeine dose

Renal NIRS values 6 hours after caffeine broken down by baseline average

Doses with baseline <20% (12 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	15.4	15.03 – 23.82

Doses with baseline 20-29.99% (16 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	35.18	24.22 – 43.08

Doses with baseline 30-39.99% (18 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	40.62	33.47 – 51.59

Doses with baseline 40-49.99% (13 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	49.97	44.94 – 57.21

Doses with baseline 50-59.99% (21 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	55.8	43.07 – 65.74

Doses with baseline >60% (76 caffeine doses)

Group	Value	95% CI
NIRS Monitoring	70.09	62.65 – 79.39

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Near Infrared Spectroscopy

Trials testing the same drug.

NCT06126133 — Evaluation of Lumbar Plexus Block Success With Near Infrared Spectroscopy (NIRS) · NA · unknown
NCT05618509 — Immediate Effects of STENDO on the Walking Abilities of Patients with COPD (STENDO-COPD) · NA · completed
NCT04223089 — Accuracy of TCOM vs NIRS in Predicting Wound Outcomes in Patients Treated With or Without Revascularization · completed
NCT03604029 — Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities · unknown
NCT03060239 — Exploration of the Mechanism of Movement Improvement During RBD in Parkinson's Disease Using NIRS · NA · completed

Other recruiting trials for Acute Kidney Injury

Currently open trials in the same condition.

NCT07273838 — Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome · Phase 2 · recruiting
NCT07262320 — Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America · recruiting
NCT07351149 — Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery · recruiting
NCT07215702 — A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kid · Phase 2 · recruiting
NCT06654193 — Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury · Phase 1, PHASE2 · recruiting

Other University of Wisconsin, Madison trials

Trials by the same sponsor.

NCT07440004 — Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts · Phase 1 · recruiting
NCT07278466 — The COMParing App Support Strategies Study · NA · recruiting
NCT07475104 — Redesigning Surgical Care for Patients in Wisconsin · NA · enrolling by invitation
NCT07470723 — The ORIGIN-FH Study · NA · recruiting
NCT06975657 — Well-being Skills for Reentry · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03384173 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
Last refreshed: 29 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03384173.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03384173: nNIRS-AKI

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Near Infrared Spectroscopy

Other recruiting trials for Acute Kidney Injury

Other University of Wisconsin, Madison trials

Verify against primary sources