Clinical Trial

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

Completed
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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.
Trial Details
NCT Number NCT07743099
Lead Sponsor Agah Bahadır Öztürk,MD
Conditions Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonatal, Asphyxia Neonatorum
Enrollment 46 participants
Start Date 2021-01-01
Primary Completion 2021-06-30 (estimated)
Study Completion 2021-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-14