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

NCT07743099 | Completed

• 1 other identifier: Etik K.No:248 (Kayseri CH)
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Near-Infrared Spectroscopy; Renal Oxygenation; Cerebral Oxygenation; Therapeutic Hypothermia; Acute Kidney Injury; Hypoxic-Ischemic Encephalopathy; Neonate; Tubular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 (%).

  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

  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

  At 24, 48, and 72 hours after initiation of therapeutic hypothermia.

• Renal Tubular Function Indices

  At 24, 48, and 72 hours after initiation of therapeutic hypothermia.

• Urinary Calcium/Creatinine and Magnesium/Creatinine Ratios

  At 24, 48, and 72 hours after initiation of therapeutic hypothermia.

• Systolic, Diastolic, and Mean Arterial Blood Pressure

  Throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values.

Study Arms (2)

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.

Diagnostic Test: Continuous Cerebral and 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.

Diagnostic Test: Continuous Cerebral and Bilateral Renal Near-Infrared Spectroscopy

Interventions

Continuous Cerebral and Bilateral Renal Near-Infrared Spectroscopy DIAGNOSTIC_TEST

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

Group 1; Group 2

Eligibility Criteria

• Age: 0 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agah Bahadır Öztürk,MD: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kayseri, 38090, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 25631390 RESULT

• Shah 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.

  PMID: 14977901 RESULT

• Jobsis 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.

  PMID: 929199 RESULT

• van 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.

  PMID: 18784420 RESULT

• Charlton 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.

  PMID: 31738181 RESULT

• Selewski 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.

  PMID: 26169430 RESULT

• Jacobs 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.

  PMID: 23440789 RESULT

• Lee 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.

  PMID: 24366463 RESULT

• Selewski 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.

  PMID: 23149172 RESULT

• Gupta 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.

  PMID: 26857710 RESULT

• Bonsante 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.

  PMID: 30645992 RESULT

• Chock 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.

  PMID: 29866591 RESULT

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Acute Kidney Injury; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Pediatrics

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 3, 2026
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the main results and will remain available for 5 years thereafter, upon reasonable request to the corresponding author.
• Access Criteria: Qualified researchers may request access by contacting the corresponding author. Requests will be evaluated for scientific merit and consistency with the original ethics approval, and a data-use agreement may be required before de-identified data are shared.

Locations

TU (1)