NIRS Monitoring in the NICU and AKI

NCT ID: NCT07222722

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-04-01

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.

Conditions

Acute Kidney Injury (AKI); Postnatal AKI

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NICU patients born less than 30 weeks gestational age

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

Group Type: EXPERIMENTAL

NIRS Monitoring

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 30 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sourabh Verma, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jordan Nelson, MD

Role: CONTACT

Jordan.nelson@nyulangone.org

3478223664

Other Identifiers

25-00172

Identifier Type: -

Identifier Source: org_study_id