Acute Kidney Injury (AKI), Postnatal AKI
Conditions
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.
Interventions
DEVICENIRS 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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 30 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| Duration of Mechanical Ventilation | Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations) |
Countries
United States
Contacts
Primary ContactJordan Nelson, MD
Outcome results
None listed