NIRS Monitoring in the NICU and AKI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NIRS Monitoring.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury (AKI), Postnatal AKI. Basic parameters: 24 Weeks — 30 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Near Infrared Spectroscopy (NIRS) Monitoring as an Early Predictor of Acute Kidney Injury (AKI) in a Vulnerable Neonatal Intensive Care Unit (NICU) Population
Overview
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.
Interventions
- 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.
Primary outcome measures
- Average NIRS Value (SrSO2) [Time frame: Up to Day-of-life 7]
Secondary outcome measures (5)
- Serum Creatinine Values [Time frame: Day-of-life 1, Day-of-life 3, Day-of-life 7, Day-of-life 14]
- Average Urine Output [Time frame: Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)]
- Length-of-Stay in NICU [Time frame: Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)]
- Duration of Non-Invasive Ventilation [Time frame: Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)]
- Duration of Mechanical Ventilation [Time frame: Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07222722 · 25-00172