NCT07222722

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 24 Weeks – 30 Weeks
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-10-30
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study