NIRS Monitoring in the NICU and AKI

Not Applicable

Recruiting

• Conditions: Acute Kidney Injury (AKI); Postnatal AKI

• Registration Number: NCT07222722
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-29
• Study First Submitted QC: 2025-10-29
• Last Update Submitted: 2025-10-29
• Study First Posted: 2025-10-30
• Last Update Posted: 2025-10-30
• Study Start: 2025-11-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of Mechanical Ventilation	Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
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)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States