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NCT07743099

Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia

Sponsor: Agah Bahadır Öztürk,MD

View on ClinicalTrials.gov

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

2026-08-03

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Continuous Cerebral and Bilateral Renal Near-Infrared Spectroscopy

Name: Continuous Cerebral and Bilateral Renal Near-Infrared Spectroscopy Description: Regional oxygen saturation was monitored continuously for 72 hours during therapeutic hypothermia using a cerebral/somatic oximeter. A neonatal sensor was applied to the right lateral forehead for cerebral measurement, and bilateral sensors were placed lateral to the lumbar spine at the T12-L2 vertebral level for renal measurement. Sensor position and skin integrity were verified every 4 to 6 hours. Recordings were time-synchronized with pulse oximetry and averaged into 6-hour intervals. Monitoring was observational; therapeutic hypothermia was delivered as standard clinical care and was not assigned by the study protocol. Arm/Group Labels: Acute Kidney Injury; No Acute Kidney Injury

Locations (1)

Kayseri City Hospital

Kayseri, Kayseri, Turkey (Türkiye)