Near Infrared Spectroscopy (NIRS) Monitoring as an Early Predictor of Acute Kidney Injury (AKI) in a Vulnerable Neonatal Intensive Care Unit (NICU) Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Average NIRS Value (SrSO2)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 24 Weeks to 30 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
NICU patients born less than 30 weeks gestational age
All patients included in the study will be assigned to receive NIRS monitoring.
Intervention: NIRS Monitoring (Device)
Outcomes
Primary Outcomes
Average NIRS Value (SrSO2)
Time Frame: Up to Day-of-life 7
NIRS values measured as renal tissue oxygen saturation (SrSO2); measured continuously over first 7 days of life.
Secondary Outcomes
- 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))