Acute Kidney Injury (AKI)NCT07222722
NIRS Monitoring in the NICU and AKI
A study testing NIRS Monitoring in people with Acute Kidney Injury (AKI) and Postnatal AKI, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary objective of this study is to describe the pattern of renal tissue oxygen saturation (SrSO2) using near-infrared spectroscopy (NIRS) in premature infants <30 weeks gestational age. Read more about this study
- Who is it for?
- Ages 24 to 30 weeksHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury (AKI), Postnatal AKI
- What is being tested?
- NIRS Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2025to 31 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 30 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any neonate less than 30 weeks in gestational age
- Willingness and capacity of both adult parents/guardians to sign consent
Who cannot join
- An infant with known congenital anomalies of the kidney (i.e., grade 4 or 5 vesicoureteral reflux (VUR), posterior urethral valves, moderate or severe hydronephrosis, autosomal recessive polycystic kidney disease (ARPKD), bilateral renal agenesis or dysplasia)
- Age >30 weeks gestational age
- Age <24 weeks and <500 grams (will be excluded due to sensitivity of skin in this vulnerable population).
- Clinician's decision that NIRS is not suitable due to the patient's clinical condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sourabh Verma, MD contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Near Infrared Spectroscopy (NIRS) Monitoring as an Early Predictor of Acute Kidney Injury (AKI) in a Vulnerable Neonatal Intensive Care Unit (NICU) Population
The primary objective of this study is to describe the pattern of renal tissue oxygen saturation (SrSO2) using near-infrared spectroscopy (NIRS) in premature infants <30 weeks gestational age. The secondary objective of this study is to evaluate prenatal and postnatal risk factors for acute kidney injury (AKI) in premature infants <30 weeks gestational age. The investigators will also compare various rates of complications including death, length-of-stay, and prolonged duration of mechanical ventilation, among others.
- Conditions
- Acute Kidney Injury (AKI), Postnatal AKI
- Being tested
- NIRS Monitoring
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS MonitoringDevice
The renal NIRS device is a non-invasive tool that uses near-infrared light to measure oxygen saturation various tissues. Renal NIRS sensors will be placed by 24 hours of the participants' admission.
| Study group | Role | What they receive |
|---|---|---|
| NICU patients born less than 30 weeks gestational age | Experimental | All patients included in the study will be assigned to receive NIRS monitoring. Receives: Device: NIRS Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average NIRS Value (SrSO2)
NIRS values measured as renal tissue oxygen saturation (SrSO2); measured continuously over first 7 days of life.
Measured: Up to Day-of-life 7
Secondary outcomes (5)
Serum Creatinine Values
Measured: Day-of-life 1, Day-of-life 3, Day-of-life 7, Day-of-life 14
Average Urine Output
Measured: Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
Length-of-Stay in NICU
Measured: Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
Duration of Non-Invasive Ventilation
Measured: Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
Duration of Mechanical Ventilation
Measured: Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start24 Jun 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (AKI)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sourabh Verma, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222722
- Sponsor's protocol ID
- 25-00172
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jordan.nelson@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.