NIRS Monitoring for Acute Kidney Injury

Overseen By Jordan Nelson, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Congenital kidney anomalies, Age >30 weeks, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to monitor oxygen levels in the kidneys of premature infants using near-infrared spectroscopy (NIRS). The goal is to understand changes in kidney oxygen levels and identify potential causes of kidney problems in these babies. It specifically targets infants born before 30 weeks of pregnancy, excluding those with certain kidney issues. Families considering participation must agree to the trial. This research could improve care for these vulnerable newborns by identifying risks early. As an unphased study, this trial offers families the opportunity to contribute to groundbreaking research that could enhance future care for premature infants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that NIRS monitoring is safe for premature infants?

Research shows that Near-Infrared Spectroscopy (NIRS) is increasingly used to monitor kidney oxygen levels in newborns, including those born prematurely. This method helps detect changes in blood flow to the kidneys, which might indicate acute kidney injury (AKI). So far, studies have not identified any major safety issues with NIRS. As a non-invasive technique, it does not involve surgery or entering the body. Research has not directly linked any serious side effects to NIRS, suggesting it is generally safe and well-tolerated for checking kidney health in newborns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NIRS Monitoring for acute kidney injury in NICU patients because it offers a non-invasive way to closely monitor kidney function in real-time. Unlike traditional methods that rely on blood tests and imaging, which can be invasive and time-consuming, NIRS (Near-Infrared Spectroscopy) provides continuous monitoring, potentially allowing for earlier detection of kidney issues. This technique can help clinicians intervene more promptly, which is crucial for premature infants who are particularly vulnerable to rapid changes in their condition.

What evidence suggests that NIRS Monitoring is effective for acute kidney injury?

Research has shown that Near-Infrared Spectroscopy (NIRS) can monitor kidney health by detecting low blood flow to the kidneys. Studies have found that when NIRS measures a drop in kidney oxygen levels, it can lead to poor outcomes, such as a higher risk of acute kidney injury (AKI). NIRS can identify these low oxygen levels early, allowing for quicker medical action. While most research highlights NIRS's potential to identify risks, its ability to track kidney oxygen levels could help manage AKI in premature babies. In this trial, all NICU patients born before 30 weeks gestational age will receive NIRS monitoring. Overall, NIRS appears promising in helping doctors monitor and possibly improve kidney health in these vulnerable patients. ^{2 5 6 7 8}

Who Is on the Research Team?

Sourabh Verma, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for premature infants born before 30 weeks of gestation. It aims to monitor kidney health using NIRS technology and assess risk factors for acute kidney injury (AKI). Specific eligibility criteria are not provided, so it's assumed that all such infants in the NICU could be potential participants.

Inclusion Criteria

My baby was born before 30 weeks of pregnancy.

Both of my child's guardians can and will sign the consent.

Exclusion Criteria

Clinician's decision that NIRS is not suitable due to the patient's clinical condition

My infant has a serious kidney condition from birth.

I was born after more than 30 weeks of pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Monitoring

Participants receive NIRS monitoring to measure renal tissue oxygen saturation (SrSO2)

7 days

Continuous monitoring in NICU

Follow-up

Participants are monitored for safety and effectiveness after the initial monitoring period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NIRS Monitoring

Trial Overview The study is testing the use of near-infrared spectroscopy (NIRS) to measure renal tissue oxygen saturation in preterm infants. The goal is to understand patterns related to AKI and evaluate prenatal/postnatal risks, while also observing complications like death or need for prolonged mechanical ventilation.

How Is the Trial Designed?

Group I: NICU patients born less than 30 weeks gestational age Experimental Treatment 1 Intervention

All patients included in the study will be assigned to receive NIRS monitoring.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8207845/

Investigating the Effect of Near Infra-Red Spectroscopy (NIRS ... 4.4.​​ The results showed that the secondary outcomes were worse in patients with CSA-AKI, including reoperation (P = 0.009), hepatic dysfunction (P = 0.031), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01382758

Near Infrared Spectroscopy for the Detection of Acute ... NIRS is a skin monitor that can detect low blood flow to the kidney and might help diagnose AKI when it occurs in the operating room.

3. nature.com nature.com/articles/s41598-024-51886-y

Near-infrared spectroscopy for kidney oxygen monitoring in ... These data shed light on other human studies of kidney NIRS which have shown association with renal vein oxygen saturation and outcome.

4. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-03296-4

Decreased renal or cerebral oxygen saturation increases the ... AKI occurred in 38% (6/16) of patients with isolated renal desaturation, 50% (5/10) with isolated cerebral desaturation, and 100% (7/7) of those ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S002252231201536X

Urinary biomarkers and renal near-infrared spectroscopy ... Our study found that increased time spent with NIRS rSO2 less than 50% was associated with a poor outcome. Assuming that the NIRS probe is measuring the mixed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12479348/

Evaluation of kidney oxygenation monitoring with near ... NIRS monitoring to detect changes in kidney oxygenation in both preterm and term neonates is being used with increasing frequency, and baseline ...

7. hvt-journal.com hvt-journal.com/articles/art526

Perioperative renal oximetry via near-infrared spectroscopy ... The aim of our study was to establish whether there is a relation between rSO2 values measured by NIRS in early AKI in infants following cardiac surgery.

8. bmjopen.bmj.com bmjopen.bmj.com/content/15/4/e097459

Near-infrared spectroscopy to monitor cerebral and renal ... This study aims to investigate the associations between intraoperative cerebral/renal rSO₂ fluctuations monitored by NIRS and postoperative neurological injury ...