Clinical Research Directory
Browse clinical research sites, groups, and studies.
Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia
Sponsor: Agah Bahadır Öztürk,MD
Summary
This prospective, single-center observational cohort study evaluated whether continuous cerebral and bilateral renal near-infrared spectroscopy (NIRS) monitoring during therapeutic hypothermia distinguishes term neonates with hypoxic-ischemic encephalopathy (HIE) who develop acute kidney injury (AKI) from those who do not. Forty-six neonates who received whole-body therapeutic hypothermia for HIE were enrolled and monitored continuously for 72 hours. Regional oxygen saturation was recorded at three sites: the cerebral cortex and both kidneys. Acute kidney injury was classified after the monitoring period using serum creatinine-based criteria, and participants were assigned to an AKI group or a non-AKI group. The primary objective was to compare regional oxygen saturation between the two groups. Serum and urinary indices of tubular function were assessed at 24, 48, and 72 hours as secondary measures.
Official title: Renal Oxygen Saturation Measured by Near-Infrared Spectroscopy for the Early Recognition of Acute Kidney Injury in Asphyxiated Neonates Undergoing Therapeutic Hypothermia: A Prospective Observational Cohort Study
Key Details
Gender
All
Age Range
0 Minutes - 6 Hours
Study Type
OBSERVATIONAL
Enrollment
46
Start Date
2021-01-01
Completion Date
2021-06-30
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
Interventions
1- Continuous Cerebral Near-Infrared Spectroscopy
Cerebral regional oxygen saturation (crSO₂) was monitored continuously for 72 hours during therapeutic hypothermia using a cerebral/somatic near-infrared spectroscopy oximeter. A neonatal sensor was applied to the right lateral forehead. Sensor position and skin integrity were verified every 4 to 6 hours. NIRS recordings were time-synchronized with pulse oximetry and averaged into 6-hour intervals for analysis. Monitoring was observational; therapeutic hypothermia was provided as standard clinical care and was not assigned or modified by the study protocol. Arm/Group Labels: Acute Kidney Injury; No Acute Kidney Injury
2- Continuous Bilateral Renal Near-Infrared Spectroscopy
Bilateral renal regional oxygen saturation (rrSO₂) was monitored continuously for 72 hours during therapeutic hypothermia using a cerebral/somatic near-infrared spectroscopy oximeter. Neonatal sensors were placed bilaterally over the renal regions, lateral to the lumbar spine at approximately the T12-L2 vertebral level. Sensor position and skin integrity were verified every 4 to 6 hours. NIRS recordings were time-synchronized with pulse oximetry and averaged into 6-hour intervals for analysis. Monitoring was observational; therapeutic hypothermia was provided as standard clinical care and was not assigned or modified by the study protocol. Arm/Group Labels: Acute Kidney Injury No Acute Kidney Injury
Locations (1)
Kayseri City Hospital
Kayseri, Kayseri, Turkey (Türkiye)