Hypoxic-Ischemic EncephalopathyNCT07743099
Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia
An observational study of Hypoxic-Ischemic Encephalopathy and Acute Kidney Injury, run by Agah Bahadır Öztürk,MD at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 0 minutes to 6 hours
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonatal
- What is being tested?
- 1- Continuous Cerebral Near-Infrared Spectroscopy and 2- Continuous Bilateral Renal Near-Infrared Spectroscopy
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Gestational age 36 weeks or more.
- Birth weight 2,000 g or more.
- Initiation of whole-body therapeutic hypothermia within 6 hours of birth.
- Diagnosis of hypoxic-ischemic encephalopathy, defined by one or more of the following: cord or first-hour arterial pH 7.0 or below, or base excess -16 mmol/L or lower; 10-minute Apgar score 5 or below, or ongoing resuscitation requirement; amplitude-integrated EEG abnormality (lower margin below 5 μV, and/or upper margin below 10 μV, and/or seizure activity); modified Sarnat and Sarnat moderate-to-severe grading, or Thompson score above 7.
- Written informed consent provided by a parent or legal guardian.
Who cannot join
- Gestational age below 36 weeks.
- Birth weight below 2,000 g.
- Age greater than 6 hours at initiation of therapeutic hypothermia.
- Congenital renal anomaly.
- Uncontrolled persistent pulmonary hypertension, or another life-threatening cardiovascular or respiratory condition.
- Major congenital anomaly, including trisomy 13, trisomy 18, or multiple organ malformations.
- Uncontrolled life-threatening hemorrhage, including intracranial hemorrhage.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonatal, Asphyxia Neonatorum
- Being tested
- 1- Continuous Cerebral Near-Infrared Spectroscopy, 2- Continuous Bilateral Renal Near-Infrared Spectroscopy
- Keywords
- Near-Infrared Spectroscopy, Renal Oxygenation, Cerebral Oxygenation, Therapeutic Hypothermia, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonate, Tubular Dysfunction
- Medical subject headings
- Hypoxia-Ischemia, Brain, Acute Kidney Injury, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1- Continuous Cerebral Near-Infrared SpectroscopyDiagnostic test
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 SpectroscopyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 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. Receives: Diagnostic Test: 1- Continuous Cerebral Near-Infrared Spectroscopy; Diagnostic Test: 2- Continuous Bilateral Renal Near-Infrared Spectroscopy | |
| Group 2 | No Acute Kidney Injury (n=34) - Neonates with HIE undergoing therapeutic hypothermia who did not meet acute kidney injury criteria; identical monitoring. Receives: Diagnostic Test: 1- Continuous Cerebral Near-Infrared Spectroscopy; Diagnostic Test: 2- Continuous Bilateral Renal Near-Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 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.
Secondary outcomes (5)
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 (%).
Measured: 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.
Measured: 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 (%).
Measured: 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).
Measured: 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.
Measured: Throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agah Bahadır Öztürk,MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Agah Bahadır Öztürk,MD, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743099
- Sponsor's protocol ID
- Etik K.No:248 (Kayseri CH)
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ruf B, Bonelli V, Balling G, Horer J, Nagdyman N, Braun SL, Ewert P, Reiter K. Intraoperative renal near-infrared spectroscopy indicates developing acute kidney injury in infants undergoing cardiac surgery with cardiopulmonary bypass: a case-control study. Crit Care. 2015 Jan 29;19(1):27. doi: 10.1186/s13054-015-0760-9.
PubMed 25631390Shah P, Riphagen S, Beyene J, Perlman M. Multiorgan dysfunction in infants with post-asphyxial hypoxic-ischaemic encephalopathy. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F152-5. doi: 10.1136/adc.2002.023093.
PubMed 14977901Jobsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. doi: 10.1126/science.929199.
PubMed 929199van Bel F, Lemmers P, Naulaers G. Monitoring neonatal regional cerebral oxygen saturation in clinical practice: value and pitfalls. Neonatology. 2008;94(4):237-44. doi: 10.1159/000151642. Epub 2008 Sep 11.
PubMed 18784420Charlton JR, Boohaker L, Askenazi D, Brophy PD, D'Angio C, Fuloria M, Gien J, Griffin R, Hingorani S, Ingraham S, Mian A, Ohls RK, Rastogi S, Rhee CJ, Revenis M, Sarkar S, Smith A, Starr M, Kent AL; Neonatal Kidney Collaborative. Incidence and Risk Factors of Early Onset Neonatal AKI. Clin J Am Soc Nephrol. 2019 Feb 7;14(2):184-195. doi: 10.2215/CJN.03670318. Epub 2019 Jan 31.
PubMed 31738181Selewski DT, Charlton JR, Jetton JG, Guillet R, Mhanna MJ, Askenazi DJ, Kent AL. Neonatal Acute Kidney Injury. Pediatrics. 2015 Aug;136(2):e463-73. doi: 10.1542/peds.2014-3819. Epub 2015 Jul 13.
PubMed 26169430Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
PubMed 23440789Lee AC, Kozuki N, Blencowe H, Vos T, Bahalim A, Darmstadt GL, Niermeyer S, Ellis M, Robertson NJ, Cousens S, Lawn JE. Intrapartum-related neonatal encephalopathy incidence and impairment at regional and global levels for 2010 with trends from 1990. Pediatr Res. 2013 Dec;74 Suppl 1(Suppl 1):50-72. doi: 10.1038/pr.2013.206.
PubMed 24366463Selewski DT, Jordan BK, Askenazi DJ, Dechert RE, Sarkar S. Acute kidney injury in asphyxiated newborns treated with therapeutic hypothermia. J Pediatr. 2013 Apr;162(4):725-729.e1. doi: 10.1016/j.jpeds.2012.10.002. Epub 2012 Nov 10.
PubMed 23149172Gupta C, Massaro AN, Ray PE. A new approach to define acute kidney injury in term newborns with hypoxic ischemic encephalopathy. Pediatr Nephrol. 2016 Jul;31(7):1167-78. doi: 10.1007/s00467-016-3317-5. Epub 2016 Feb 8.
PubMed 26857710Bonsante F, Ramful D, Binquet C, Samperiz S, Daniel S, Gouyon JB, Iacobelli S. Low Renal Oxygen Saturation at Near-Infrared Spectroscopy on the First Day of Life Is Associated with Developing Acute Kidney Injury in Very Preterm Infants. Neonatology. 2019;115(3):198-204. doi: 10.1159/000494462. Epub 2019 Jan 15.
PubMed 30645992Chock VY, Frymoyer A, Yeh CG, Van Meurs KP. Renal Saturation and Acute Kidney Injury in Neonates with Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia. J Pediatr. 2018 Sep;200:232-239.e1. doi: 10.1016/j.jpeds.2018.04.076. Epub 2018 Jun 1.
PubMed 29866591
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07743099
- Acronym / sponsor ID
- Etik K.No:248 (Kayseri CH)
- Conditions
- Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonatal, Asphyxia Neonatorum
- Keywords
- Near-Infrared Spectroscopy, Renal Oxygenation, Cerebral Oxygenation, Therapeutic Hypothermia, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonate, Tubular Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Agah Bahadır Öztürk,MDOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: 1- Continuous Cerebral Near-Infrared Spectroscopy, Diagnostic Test: 2- Continuous Bilateral Renal Near-Infrared SpectroscopyAcute 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. |
| Group 2 | – | Diagnostic Test: 1- Continuous Cerebral Near-Infrared Spectroscopy, Diagnostic Test: 2- Continuous Bilateral Renal Near-Infrared SpectroscopyNo Acute Kidney Injury (n=34) - Neonates with HIE undergoing therapeutic hypothermia who did not meet acute kidney injury criteria; identical monitoring. |
Who may qualify
- Ages
- 0 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (5 listed)
- Gestational age 36 weeks or more.
- Birth weight 2,000 g or more.
- Initiation of whole-body therapeutic hypothermia within 6 hours of birth.
- Diagnosis of hypoxic-ischemic encephalopathy, defined by one or more of the following: cord or first-hour arterial pH 7.0 or below, or base excess -16 mmol/L or lower; 10-minute Apgar score 5 or below, or ongoing resuscitation requirement; amplitude-integrated EEG abnormality (lower margin below 5 μV, and/or upper margin below 10 μV, and/or seizure activity); modified Sarnat and Sarnat moderate-to-severe grading, or Thompson score above 7.
- Written informed consent provided by a parent or legal guardian.
Key exclusion criteria (7 listed)
- Gestational age below 36 weeks.
- Birth weight below 2,000 g.
- Age greater than 6 hours at initiation of therapeutic hypothermia.
- Congenital renal anomaly.
- Uncontrolled persistent pulmonary hypertension, or another life-threatening cardiovascular or respiratory condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1- Continuous Cerebral Near-Infrared SpectroscopyCerebral 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 | Diagnostic test | Group 1, Group 2 |
| 2- Continuous Bilateral Renal Near-Infrared SpectroscopyBilateral 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 | Diagnostic test | Group 1, Group 2 |
Primary outcome
Renal Regional Oxygen Saturation Measured by Near-Infrared Spectroscopy
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.
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 (%).
5 secondary outcomes
Cerebral Regional Oxygen Saturation Measured by Near-Infrared Spectroscopy
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
Time frame: At 24, 48, and 72 hours after initiation of therapeutic hypothermia.
Renal Tubular Function Indices
Time frame: At 24, 48, and 72 hours after initiation of therapeutic hypothermia.
Urinary Calcium/Creatinine and Magnesium/Creatinine Ratios
Time frame: At 24, 48, and 72 hours after initiation of therapeutic hypothermia.
Systolic, Diastolic, and Mean Arterial Blood Pressure
Time frame: Throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Results publication: PubMed 25631390Ruf B, Bonelli V, Balling G, Horer J, Nagdyman N, Braun SL, Ewert P, Reiter K. Intraoperative renal near-infrared spectroscopy indicates developing acute kidney injury in infants undergoing cardiac surgery with cardiopulmonary bypass: a case-control study. Crit Care. 2015 Jan 29;19(1):27. doi: 10.1186/s13054-015-0760-9.
- Results publication: PubMed 14977901Shah P, Riphagen S, Beyene J, Perlman M. Multiorgan dysfunction in infants with post-asphyxial hypoxic-ischaemic encephalopathy. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F152-5. doi: 10.1136/adc.2002.023093.
- Results publication: PubMed 929199Jobsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. doi: 10.1126/science.929199.
- Results publication: PubMed 18784420van Bel F, Lemmers P, Naulaers G. Monitoring neonatal regional cerebral oxygen saturation in clinical practice: value and pitfalls. Neonatology. 2008;94(4):237-44. doi: 10.1159/000151642. Epub 2008 Sep 11.
- Results publication: PubMed 31738181Charlton JR, Boohaker L, Askenazi D, Brophy PD, D'Angio C, Fuloria M, Gien J, Griffin R, Hingorani S, Ingraham S, Mian A, Ohls RK, Rastogi S, Rhee CJ, Revenis M, Sarkar S, Smith A, Starr M, Kent AL; Neonatal Kidney Collaborative. Incidence and Risk Factors of Early Onset Neonatal AKI. Clin J Am Soc Nephrol. 2019 Feb 7;14(2):184-195. doi: 10.2215/CJN.03670318. Epub 2019 Jan 31.
- Results publication: PubMed 26169430Selewski DT, Charlton JR, Jetton JG, Guillet R, Mhanna MJ, Askenazi DJ, Kent AL. Neonatal Acute Kidney Injury. Pediatrics. 2015 Aug;136(2):e463-73. doi: 10.1542/peds.2014-3819. Epub 2015 Jul 13.
- Results publication: PubMed 23440789Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
- Results publication: PubMed 24366463Lee AC, Kozuki N, Blencowe H, Vos T, Bahalim A, Darmstadt GL, Niermeyer S, Ellis M, Robertson NJ, Cousens S, Lawn JE. Intrapartum-related neonatal encephalopathy incidence and impairment at regional and global levels for 2010 with trends from 1990. Pediatr Res. 2013 Dec;74 Suppl 1(Suppl 1):50-72. doi: 10.1038/pr.2013.206.
- Results publication: PubMed 23149172Selewski DT, Jordan BK, Askenazi DJ, Dechert RE, Sarkar S. Acute kidney injury in asphyxiated newborns treated with therapeutic hypothermia. J Pediatr. 2013 Apr;162(4):725-729.e1. doi: 10.1016/j.jpeds.2012.10.002. Epub 2012 Nov 10.
- Results publication: PubMed 26857710Gupta C, Massaro AN, Ray PE. A new approach to define acute kidney injury in term newborns with hypoxic ischemic encephalopathy. Pediatr Nephrol. 2016 Jul;31(7):1167-78. doi: 10.1007/s00467-016-3317-5. Epub 2016 Feb 8.
- Results publication: PubMed 30645992Bonsante F, Ramful D, Binquet C, Samperiz S, Daniel S, Gouyon JB, Iacobelli S. Low Renal Oxygen Saturation at Near-Infrared Spectroscopy on the First Day of Life Is Associated with Developing Acute Kidney Injury in Very Preterm Infants. Neonatology. 2019;115(3):198-204. doi: 10.1159/000494462. Epub 2019 Jan 15.
- Results publication: PubMed 29866591Chock VY, Frymoyer A, Yeh CG, Van Meurs KP. Renal Saturation and Acute Kidney Injury in Neonates with Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia. J Pediatr. 2018 Sep;200:232-239.e1. doi: 10.1016/j.jpeds.2018.04.076. Epub 2018 Jun 1.
- Individual participant dataSharing planned: 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.
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Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic-Ischemic Encephalopathy and Acute Kidney Injury, run by Agah Bahadır Öztürk,MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Regional Oxygen Saturation Measured by Near-Infrared Spectroscopy (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07743099, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.