MedTrace Logo

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

NCT07743099 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Hypoxic-Ischemic Encephalopathy
  • Acute Kidney Injury
  • Hypoxic-Ischemic Encephalopathy, Neonatal
  • Asphyxia Neonatorum

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

Sponsors & Collaborators

  • Agah Bahadır Öztürk,MD

    lead OTHER_GOV

Eligibility

Min Age
0 Minutes
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07743099 on ClinicalTrials.gov