An observational study in Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury and Hypoxic-Ischemic Encephalopathy, Neonatal, sponsored by Agah Bahadır Öztürk,MD. Completed at 1 site in Turkey (Türkiye). Open to participants aged 0 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Agah Bahadır Öztürk,MD · Observational
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.
Acute kidney injury is among the most frequent organ complications of perinatal asphyxia, and serum creatinine rises only after substantial functional loss has already occurred. Near-infrared spectroscopy provides continuous, non-invasive measurement of regional tissue oxygen saturation and may detect renal compromise earlier than conventional biochemical markers, but data in neonates undergoing therapeutic hypothermia remain limited.
This single-center prospective observational cohort study was conducted in the neonatal intensive care unit of Kayseri City Training and Research Hospital, Kayseri, Türkiye. Consecutive neonates with hypoxic-ischemic encephalopathy who began whole-body therapeutic hypothermia within 6 hours of birth were enrolled. All clinical management followed the unit's pre-existing standing protocol for therapeutic hypothermia and was not assigned, modified, or withheld for research purposes. Under that routine protocol, core temperature was maintained at 33.5 °C for 72 hours with servo-controlled feedback, followed by rewarming at 0.25 °C per hour; all neonates received ampicillin and cefotaxime because of infection risk, antibiotics were discontinued after rewarming in neonates without signs of infection, and aminoglycosides were not administered to any neonate owing to their recognized renal toxicity. The investigators recorded, but did not direct, clinical care.
Regional oxygen saturation was recorded continuously across the 72-hour cooling period using a cerebral/somatic oximeter. A neonatal sensor was placed on 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 checked every 4 to 6 hours. Recordings were time-synchronized with pulse oximetry and averaged into 6-hour intervals.
Serum and spot urine samples were obtained at 24, 48, and 72 hours for electrolytes and creatinine, from which fractional excretion of sodium and potassium, tubular reabsorption of phosphate, and urinary calcium/creatinine and magnesium/creatinine ratios were derived. Acute kidney injury was classified after the monitoring period using modified pediatric RIFLE criteria together with a neonatal-specific serum creatinine decline-rate criterion. Participants were then assigned to an AKI group or a non-AKI group, and regional oxygen saturation was compared between them.
234 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 83 are open to participants now.
This study's enrollment of 46 is below the median of 100 across 87 observational studies indexed under Hypoxia-Ischemia, Brain.
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Term and late-preterm neonates of gestational age 36 weeks or more admitted to the neonatal intensive care unit of Kayseri City Hospital, Kayseri, Türkiye, with a diagnosis of hypoxic-ischemic encephalopathy and treated with whole-body therapeutic hypothermia initiated within 6 hours of birth. Participants were enrolled consecutively from eligible admissions between January and June 2021.
Exclusion Criteria:
Acute Kidney Injury (n=12) - Neonates with HIE undergoing therapeutic hypothermia who met acute kidney injury criteria during the first 72 hours; continuous cerebral and bilateral renal NIRS monitoring.
Diagnostic Test: 1- Continuous Cerebral Near-Infrared Spectroscopy · Diagnostic Test: 2- Continuous Bilateral Renal Near-Infrared Spectroscopy
No Acute Kidney Injury (n=34) - Neonates with HIE undergoing therapeutic hypothermia who did not meet acute kidney injury criteria; identical monitoring.
Diagnostic Test: 1- Continuous Cerebral Near-Infrared Spectroscopy · Diagnostic Test: 2- Continuous Bilateral Renal 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
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
Renal Regional Oxygen Saturation Measured by Near-Infrared Spectroscopy
Description: Renal regional oxygen saturation recorded by near-infrared spectroscopy from bilateral sensors (left kidney, right kidney, and the mean of the two), compared between neonates who developed acute kidney injury and those who did not. Unit of measure: percent (%).
Time frame: Continuously throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values and as daily mean values for Days 1, 2, and 3.
Cerebral Regional Oxygen Saturation Measured by Near-Infrared Spectroscopy
Cerebral regional oxygen saturation recorded by near-infrared spectroscopy from a sensor on the right lateral forehead, compared between neonates who developed acute kidney injury and those who did not. Unit of measure: percent (%).
Time frame: Continuously throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values and as daily mean values for Days 1, 2, and 3.
Serum Creatinine Concentration
Serum creatinine concentration compared between neonates who developed acute kidney injury and those who did not. Unit of measure: mg/dL.
Time frame: At 24, 48, and 72 hours after initiation of therapeutic hypothermia.
Renal Tubular Function Indices
Fractional excretion of sodium, fractional excretion of potassium, and tubular reabsorption of phosphate, each derived from paired serum and spot urine samples and compared between neonates who developed acute kidney injury and those who did not. Unit of measure: percent (%).
Time frame: At 24, 48, and 72 hours after initiation of therapeutic hypothermia.
Urinary Calcium/Creatinine and Magnesium/Creatinine Ratios
Urinary calcium/creatinine and magnesium/creatinine ratios from spot urine samples, compared between neonates who developed acute kidney injury and those who did not. Unit of measure: ratio (mg/mg).
Time frame: At 24, 48, and 72 hours after initiation of therapeutic hypothermia.
Systolic, Diastolic, and Mean Arterial Blood Pressure
Systolic, diastolic, and mean arterial blood pressure compared between neonates who developed acute kidney injury and those who did not, recorded to assess whether observed differences in regional oxygen saturation were accompanied by systemic hemodynamic differences. Unit of measure: mmHg.
Time frame: Throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values.
Plan to share: Yes — De-identified individual participant data underlying the published results, including near-infrared spectroscopy recordings, demographic and clinical variables, and laboratory parameters, will be available from the corresponding author upon reasonable request. Data will be shared with qualified researchers whose proposed use has been approved and is consistent with the original ethics approval. A data-use agreement may be required.
Supporting information: Study protocol, Icf
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