NIRS Monitoring in the NICU and AKI

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury (AKI); Postnatal AKI
• Intervention / Treatment: Device: NIRS Monitoring

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordan Nelson, MD; Phone Number: 3478223664; Email: Jordan.nelson@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Any neonate less than 30 weeks in gestational age
• Willingness and capacity of both adult parents/guardians to sign consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NICU patients born less than 30 weeks gestational age; All patients included in the study will be assigned to receive NIRS monitoring.	Device: NIRS Monitoring; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average NIRS Value (SrSO2)	NIRS values measured as renal tissue oxygen saturation (SrSO2); measured continuously over first 7 days of life.	Up to Day-of-life 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum Creatinine Values	Day-of-life 1, Day-of-life 3, Day-of-life 7, Day-of-life 14
Average Urine Output	Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
Length-of-Stay in NICU	Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
Duration of Non-Invasive Ventilation	Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
Duration of Mechanical Ventilation	Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Sourabh Verma, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Estimated): October 30, 2025

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 25-00172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Jordan.nelson@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes