NIRS Monitoring in the NICU and AKI

NYU Langone Health

Status: Enrolling

Conditions: Postnatal AKI; Acute Kidney Injury (AKI)

Treatments: Device: NIRS Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07222722

25-00172

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 24 to 30 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

NICU patients born less than 30 weeks gestational age

Experimental group

Description:

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

Treatment:

Device: NIRS Monitoring