Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07222722

Conditions

Acute Kidney Injury (AKI)

Postnatal AKI

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

NIRS Monitoring

Study Details

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 ID

NCT07222722

Start date

Nov, 2025

Status verified date

Oct, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: NICU patients born less than 30 weeks gestational age

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

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.

Primary outcome measure

  • Average NIRS Value (SrSO2) [ Time Frame: Up to Day-of-life 7 ]

Central Contacts and Locations

Central contacts

Jordan Nelson, MD

3478223664Jordan.nelson@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-10-30.