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
1 other identifier
interventional
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2025
CompletedFirst Posted
Study publicly available on registry
October 30, 2025
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedOctober 30, 2025
October 1, 2025
5 months
October 29, 2025
October 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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)
Study Arms (1)
NICU patients born less than 30 weeks gestational age
EXPERIMENTALAll patients included in the study will be assigned to receive NIRS monitoring.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Any neonate less than 30 weeks in gestational age
- Willingness and capacity of both adult parents/guardians to sign consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sourabh Verma, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2025
First Posted
October 30, 2025
Study Start
November 1, 2025
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
October 30, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.