Hypoxic-Ischemic Encephalopathy MildNCT07393620
Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
An observational study of Hypoxic-Ischemic Encephalopathy Mild, run by Uludag University at 3 sites in Turkey (Türkiye).
Trial summary
Newborns with mild hypoxic-ischemic encephalopathy usually do not receive cooling treatment. However, some of these newborns may develop neurological problems later in life. This observational study aims to evaluate whether early brain monitoring and measurements of brain oxygen levels are associated with neurological… Read more about this study
- Who is it for?
- Ages 0 to 6 hours
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy Mild
- How many people
- 30 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 10 Feb 2026to 10 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 6 hours
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of newborns with a gestational age of ≥ 36 0/7 weeks who are diagnosed with mild hypoxic-ischemic encephalopathy within the first 6 hours after birth. Eligible participants include newborns with evidence of an acute peripartum or intrapartum asphyxial event who meet blood gas and clinical criteria for hypoxic-ischemic injury but do not fulfill criteria for moderate or severe encephalopathy or for therapeutic hypothermia at enrollment. Newborns will be prospectively followed from birth up to 24 months of age to assess both short-term and long-term neurological outcomes.
Who may be able to join
- Gestational age and postnatal age:
- Gestational age ≥ 36 0/7 weeks and enrollment within the first 6 hours after birth.
- Blood gas criteria
- Umbilical cord or postnatal (≤ 1 hour of life) blood gas showing:
- pH ≤ 7.00 or base deficit ≥ 16 mmol/L
- OR, if pH is 7.01-7.15 or base deficit is 10-15.9 mmol/L, the presence of both:
Show all 10Show fewer
- An acute perinatal event, and
- Apgar score ≤ 5 at 10 minutes or ongoing resuscitation at 10 minutes of life, including the need for positive pressure ventilation.
- ( Evidence of an acute peripartum and intrapartum asphyxia event, defined by at least one of the following: Uterine rupture, placental abruption, umbilical cord prolapse, rupture, tight nuchal cord, maternal hemorrhage, trauma, or cardiopulmonary arrest, vasa previa, category III fetal heart rate tracing, including having either a sinusoidal pattern or absent baseline variability plus recurrent late decelerations, recurrent variable decelerations, or bradycardia.)
- Clinical evidence of encephalopathy Findings consistent with Sarnat and Sarnat Stage 1 (mild) encephalopathy. Mild, moderate, or severe abnormalities may be present in at least one of the six categories (level of consciousness, spontaneous activity, posture, tone, primitive reflexes [suck and Moro], autonomic nervous system), provided that no more than two categories show moderate or severe findings.
Who cannot join
- Newborns meeting any of the following criteria will be excluded from the study:
- Normal neurological examination Newborns with a completely normal neurological examination according to Sarnat and Sarnat staging.
- Moderate or severe encephalopathy within the first 6 hours of life
- Clinical findings consistent with moderate or severe encephalopathy during the first 6 hours after birth.
- Presence of clinical seizures.
- aEEG findings consistent with moderate or severe encephalopathy requiring therapeutic hypothermia.
Show all 24Show fewer
- Evidence of electrographic seizure activity on aEEG monitoring.
- Sarnat and Sarnat criteria for moderate-severe encephalopathy Findings consistent with moderate or severe encephalopathy in three or more Sarnat categories, classified as moderate or severe hypoxic-ischemic encephalopathy.
- Contraindications to therapeutic hypothermia, including:
- Evaluation occurring more than 6 hours after birth.
- Gestational age < 36 weeks or birth weight < 2000 g.
- Severe or extensive intracranial parenchymal hemorrhage.
- Severe, life-threatening coagulopathy.
- Intracerebral infarction.
- Chromosomal abnormalities (e.g., trisomy 13 or 18) or major congenital anomalies involving multiple organ systems.
- Lack of parental informed consent
- Cyanotic congenital heart disease
- Metabolic encephalopathy Encephalopathy due to metabolic disorders not related to hypoxic-ischemic events.
- Other conditions associated with encephalopathy unrelated to acute hypoxia
- Abnormal fetal growth.
- Maternal infections.
- Fetomaternal hemorrhage.
- Severe neonatal sepsis.
- Chronic placental lesions.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Bursa City Hospital
Bursa
Bayram Ali Dorum, Associate professor, +90 533 7078398, bayramalidorum@gmail.com
Bayram Ali Dorum, Associate professor
- Recruiting
Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine
Bursa
Salih Çağrı Çakır, +90 533 3453739, salihcagri@uludag.edu.tr
Nilgün Köksal, Professor
- Recruiting
Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital
Bursa
İpek Güney Varal, Associate professor, +90 532 3413389, ipekguneyvaral@gmail.com
Gaffari Tunç, Associate professor
About this study
Official title: Predictive Value of Amplitude-Integrated Electroencephalography and Cerebral Tissue Oxygenation on Neurological Outcomes in Neonates With Mild Hypoxic-Ischemic Encephalopathy
Newborns with mild hypoxic-ischemic encephalopathy usually do not receive cooling treatment. However, some of these newborns may develop neurological problems later in life. This observational study aims to evaluate whether early brain monitoring and measurements of brain oxygen levels are associated with neurological outcomes in newborns with mild hypoxic-ischemic encephalopathy. Newborns will be monitored during the first 72 hours after birth as part of routine clinical care. Neurological assessments will be performed during early infancy and later follow-up. The findings of this study may help improve early risk assessment and support closer monitoring of newborns who may be at increased risk for unfavorable neurological outcomes.
Read the detailed description
Perinatal asphyxia resulting from impaired gas exchange may lead to hypoxemia, hypercapnia, and metabolic acidosis, causing injury to the brain and other organs in newborns. Perinatal asphyxia disrupts cerebral autoregulation, leading to primary and secondary energy deficiency, cerebral damage, and hypoxic-ischemic encephalopathy (HIE). HIE remains a significant cause of neonatal mortality and long-term neurological morbidity. HIE is clinically classified as mild, moderate, or severe based on neurological examination findings, most commonly using the Sarnat and Sarnat scoring system. Therapeutic hypothermia has been shown to reduce mortality and morbidity in term and near-term newborns with moderate to severe HIE when initiated within the first 6 hours after birth. However, therapeutic hypothermia is not routinely recommended for newborns with mild HIE due to the lack of sufficient evidence from randomized clinical trials. Although mild HIE is generally associated with a better prognosis, accumulating evidence suggests that a substantial proportion of newborns diagnosed with mild HIE may develop adverse neurodevelopmental outcomes during infancy and early childhood.
Furthermore, the severity of encephalopathy may evolve, and some newborns initially classified as having mild HIE may progress to moderate encephalopathy within the first hours after birth. Early identification of newborns with mild HIE who are at increased risk for neurological deterioration remains challenging, particularly during the critical first 6 hours of life. Continuous bedside brain monitoring techniques may provide valuable prognostic information in this early period. Amplitude-integrated electroencephalography (aEEG) allows continuous assessment of cerebral electrical activity. It helps evaluate the severity of encephalopathy, detect seizures, and predict neurological outcomes in newborns with HIE. Additionally, near-infrared spectroscopy (NIRS) allows for non-invasive monitoring of cerebral oxygenation and cerebral fractional tissue oxygen extraction (cFTOE). However, data regarding the use of NIRS in newborns with mild HIE are limited, particularly during the early postnatal period.
The primary objective of this prospective, multicenter observational cohort study is to investigate the association between early brain monitoring findings and short-term and long-term neurological outcomes in newborns with mild hypoxic-ischemic encephalopathy. Specifically, the study aims to evaluate early neurological findings and neurodevelopmental outcomes up to 24 months of age. Secondarily, this study aims to explore whether early aEEG and NIRS findings may help identify subgroups of newborns with mild HIE who are at higher risk for neurological deterioration and may benefit from closer monitoring and follow-up.
- Conditions
- Hypoxic-Ischemic Encephalopathy Mild
- Keywords
- Mild Hypoxic Ischemic Encephalopathy, Amplitude-integrated electroencephalography, Cerebral oxygenation, Near infrared spectroscopy, Neonates, aEEG, NIRS
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Outcomes in Neonates with Mild Hypoxic-ischemic Encephalopathy
The primary outcome measure is the report of neurological outcome in children diagnosed with mild hypoxic-ischemic encephalopathy. Neurological outcome will be measured using the Bayley Scales of Infant and Toddler Development (Bayley-III) at 18-24 months of age; a standard score below 85 in at least one of the cognitive, motor, or language domains will be defined as a neurologic disorder.
Measured: at 18 and 24 months of age
Secondary outcomes (2)
Correlation Between Early aEEG Background Patterns and Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
This outcome measure evaluates the correlation between:
- Continuous amplitude-integrated electroencephalography (aEEG) monitoring will be used within the first 72 hours of life to measure the amplitude (µV) of cerebral electrical activity and to determine background patterns and sleep-wake cycling; and
- Neurological outcomes, measured by the Bayley Scales of Infant and Toddler Development (Bayley-III) in the cognitive, motor, and language domains at 18 and 24 months of age.
Measured: aEEG: within the first 72 hours of life. Neurological outcomes: at 18 and 24 months of age, birth to 24 months of age.
Correlation Between Early Cerebral NIRS Values and Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
This outcome measure evaluates the correlation between:
- Early cerebral NIRS values within the first 72 hours of life. Cerebral oxygenation (%) values at NIRS measurements in infants, first 6 h of life, first 24 h of life, between 24-48 h, 48-72 h.
- Neurological outcomes, measured by the Bayley Scales of Infant and Toddler Development (Bayley-III) in the cognitive, motor, and language domains at 18 and 24 months of age.
Measured: Cerebral NIRS: within the first 72 hours of life. Neurological outcomes: at 18 and 24 months of age, birth to 24 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start10 Feb 2026
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic Encephalopathy MildStudies 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salih Çağrı Çakır, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393620
- Sponsor's protocol ID
- 2025/903/17-24
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I am not authorized to share patient data.
Publications
Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.
PubMed 12563063Chalak L. New Horizons in Mild Hypoxic-ischemic Encephalopathy: A Standardized Algorithm to Move past Conundrum of Care. Clin Perinatol. 2022 Mar;49(1):279-294. doi: 10.1016/j.clp.2021.11.016. Epub 2022 Jan 21.
PubMed 35210007Kariholu U, Montaldo P, Markati T, Lally PJ, Pryce R, Teiserskas J, Liow N, Oliveira V, Soe A, Shankaran S, Thayyil S. Therapeutic hypothermia for mild neonatal encephalopathy: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):225-228. doi: 10.1136/archdischild-2018-315711. Epub 2018 Dec 19.
PubMed 30567775Chalak LF, Nguyen KA, Prempunpong C, Heyne R, Thayyil S, Shankaran S, Laptook AR, Rollins N, Pappas A, Koclas L, Shah B, Montaldo P, Techasaensiri B, Sanchez PJ, Sant'Anna G. Prospective research in infants with mild encephalopathy identified in the first six hours of life: neurodevelopmental outcomes at 18-22 months. Pediatr Res. 2018 Dec;84(6):861-868. doi: 10.1038/s41390-018-0174-x. Epub 2018 Sep 13.
PubMed 30250303Prempunpong C, Chalak LF, Garfinkle J, Shah B, Kalra V, Rollins N, Boyle R, Nguyen KA, Mir I, Pappas A, Montaldo P, Thayyil S, Sanchez PJ, Shankaran S, Laptook AR, Sant'Anna G. Prospective research on infants with mild encephalopathy: the PRIME study. J Perinatol. 2018 Jan;38(1):80-85. doi: 10.1038/jp.2017.164. Epub 2017 Nov 2.
PubMed 29095433Conway JM, Walsh BH, Boylan GB, Murray DM. Mild hypoxic ischaemic encephalopathy and long term neurodevelopmental outcome - A systematic review. Early Hum Dev. 2018 May;120:80-87. doi: 10.1016/j.earlhumdev.2018.02.007. Epub 2018 Feb 26.
PubMed 29496329Murray DM, O'Connor CM, Ryan CA, Korotchikova I, Boylan GB. Early EEG Grade and Outcome at 5 Years After Mild Neonatal Hypoxic Ischemic Encephalopathy. Pediatrics. 2016 Oct;138(4):e20160659. doi: 10.1542/peds.2016-0659. Epub 2016 Sep 20.
PubMed 27650049
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Amplitude-Integrated Electroencephalography and Cerebral Tissue Oxygenation on Neurological Outcomes in Neonates With Mild Hypoxic-Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT07393620
- Acronym / sponsor ID
- 2025/903/17-24
- Conditions
- Hypoxic-Ischemic Encephalopathy Mild
- Keywords
- Mild Hypoxic Ischemic Encephalopathy, Amplitude-integrated electroencephalography, Cerebral oxygenation, Near infrared spectroscopy, Neonates, aEEG, NIRS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Feb 2029 (estimated)
- First posted
- 6 Feb 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.
Newborns with mild hypoxic-ischemic encephalopathy usually do not receive cooling treatment. However, some of these newborns may develop neurological problems later in life. This observational study aims to evaluate whether early brain monitoring and measurements of brain oxygen levels are associated with neurological outcomes in newborns with mild hypoxic-ischemic encephalopathy. Newborns will be monitored during the first 72 hours after birth as part of routine clinical care. Neurological assessments will be performed during early infancy and later follow-up. The findings of this study may help improve early risk assessment and support closer monitoring of newborns who may be at increased risk for unfavorable neurological outcomes.
Detailed description
Perinatal asphyxia resulting from impaired gas exchange may lead to hypoxemia, hypercapnia, and metabolic acidosis, causing injury to the brain and other organs in newborns. Perinatal asphyxia disrupts cerebral autoregulation, leading to primary and secondary energy deficiency, cerebral damage, and hypoxic-ischemic encephalopathy (HIE). HIE remains a significant cause of neonatal mortality and long-term neurological morbidity. HIE is clinically classified as mild, moderate, or severe based on neurological examination findings, most commonly using the Sarnat and Sarnat scoring system. Therapeutic hypothermia has been shown to reduce mortality and morbidity in term and near-term newborns with moderate to severe HIE when initiated within the first 6 hours after birth. However, therapeutic hypothermia is not routinely recommended for newborns with mild HIE due to the lack of sufficient evidence from randomized clinical trials. Although mild HIE is generally associated with a better prognosis, accumulating evidence suggests that a substantial proportion of newborns diagnosed with mild HIE may develop adverse neurodevelopmental outcomes during infancy and early childhood.
Furthermore, the severity of encephalopathy may evolve, and some newborns initially classified as having mild HIE may progress to moderate encephalopathy within the first hours after birth. Early identification of newborns with mild HIE who are at increased risk for neurological deterioration remains challenging, particularly during the critical first 6 hours of life. Continuous bedside brain monitoring techniques may provide valuable prognostic information in this early period. Amplitude-integrated electroencephalography (aEEG) allows continuous assessment of cerebral electrical activity. It helps evaluate the severity of encephalopathy, detect seizures, and predict neurological outcomes in newborns with HIE. Additionally, near-infrared spectroscopy (NIRS) allows for non-invasive monitoring of cerebral oxygenation and cerebral fractional tissue oxygen extraction (cFTOE). However, data regarding the use of NIRS in newborns with mild HIE are limited, particularly during the early postnatal period.
The primary objective of this prospective, multicenter observational cohort study is to investigate the association between early brain monitoring findings and short-term and long-term neurological outcomes in newborns with mild hypoxic-ischemic encephalopathy. Specifically, the study aims to evaluate early neurological findings and neurodevelopmental outcomes up to 24 months of age. Secondarily, this study aims to explore whether early aEEG and NIRS findings may help identify subgroups of newborns with mild HIE who are at higher risk for neurological deterioration and may benefit from closer monitoring and follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of newborns with a gestational age of ≥ 36 0/7 weeks who are diagnosed with mild hypoxic-ischemic encephalopathy within the first 6 hours after birth. Eligible participants include newborns with evidence of an acute peripartum or intrapartum asphyxial event who meet blood gas and clinical criteria for hypoxic-ischemic injury but do not fulfill criteria for moderate or severe encephalopathy or for therapeutic hypothermia at enrollment. Newborns will be prospectively followed from birth up to 24 months of age to assess both short-term and long-term neurological outcomes.
Key inclusion criteria (10 listed)
- Gestational age and postnatal age:
- Gestational age ≥ 36 0/7 weeks and enrollment within the first 6 hours after birth.
- Blood gas criteria
- ( Evidence of an acute peripartum and intrapartum asphyxia event, defined by at least one of the following: Uterine rupture, placental abruption, umbilical cord prolapse, rupture, tight nuchal cord, maternal hemorrhage, trauma, or cardiopulmonary arrest, vasa previa, category III fetal heart rate tracing, including having either a sinusoidal pattern or absent baseline variability plus recurrent late decelerations, recurrent variable decelerations, or bradycardia.)
- Clinical evidence of encephalopathy Findings consistent with Sarnat and Sarnat Stage 1 (mild) encephalopathy. Mild, moderate, or severe abnormalities may be present in at least one of the six categories (level of consciousness, spontaneous activity, posture, tone, primitive reflexes [suck and Moro], autonomic nervous system), provided that no more than two categories show moderate or severe findings.
Key exclusion criteria (24 listed)
- Normal neurological examination Newborns with a completely normal neurological examination according to Sarnat and Sarnat staging.
- Moderate or severe encephalopathy within the first 6 hours of life
- Sarnat and Sarnat criteria for moderate-severe encephalopathy Findings consistent with moderate or severe encephalopathy in three or more Sarnat categories, classified as moderate or severe hypoxic-ischemic encephalopathy.
- Contraindications to therapeutic hypothermia, including:
- Lack of parental informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurological Outcomes in Neonates with Mild Hypoxic-ischemic Encephalopathy
Time frame: at 18 and 24 months of age
The primary outcome measure is the report of neurological outcome in children diagnosed with mild hypoxic-ischemic encephalopathy. Neurological outcome will be measured using the Bayley Scales of Infant and Toddler Development (Bayley-III) at 18-24 months of age; a standard score below 85 in at least one of the cognitive, motor, or language domains will be defined as a neurologic disorder.
2 secondary outcomes
Correlation Between Early aEEG Background Patterns and Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
Time frame: aEEG: within the first 72 hours of life. Neurological outcomes: at 18 and 24 months of age, birth to 24 months of age.
Correlation Between Early Cerebral NIRS Values and Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
Time frame: Cerebral NIRS: within the first 72 hours of life. Neurological outcomes: at 18 and 24 months of age, birth to 24 months of age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 12563063Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.
- Background: PubMed 35210007Chalak L. New Horizons in Mild Hypoxic-ischemic Encephalopathy: A Standardized Algorithm to Move past Conundrum of Care. Clin Perinatol. 2022 Mar;49(1):279-294. doi: 10.1016/j.clp.2021.11.016. Epub 2022 Jan 21.
- Background: PubMed 30567775Kariholu U, Montaldo P, Markati T, Lally PJ, Pryce R, Teiserskas J, Liow N, Oliveira V, Soe A, Shankaran S, Thayyil S. Therapeutic hypothermia for mild neonatal encephalopathy: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):225-228. doi: 10.1136/archdischild-2018-315711. Epub 2018 Dec 19.
- Background: PubMed 30250303Chalak LF, Nguyen KA, Prempunpong C, Heyne R, Thayyil S, Shankaran S, Laptook AR, Rollins N, Pappas A, Koclas L, Shah B, Montaldo P, Techasaensiri B, Sanchez PJ, Sant'Anna G. Prospective research in infants with mild encephalopathy identified in the first six hours of life: neurodevelopmental outcomes at 18-22 months. Pediatr Res. 2018 Dec;84(6):861-868. doi: 10.1038/s41390-018-0174-x. Epub 2018 Sep 13.
- Background: PubMed 29095433Prempunpong C, Chalak LF, Garfinkle J, Shah B, Kalra V, Rollins N, Boyle R, Nguyen KA, Mir I, Pappas A, Montaldo P, Thayyil S, Sanchez PJ, Shankaran S, Laptook AR, Sant'Anna G. Prospective research on infants with mild encephalopathy: the PRIME study. J Perinatol. 2018 Jan;38(1):80-85. doi: 10.1038/jp.2017.164. Epub 2017 Nov 2.
- Background: PubMed 29496329Conway JM, Walsh BH, Boylan GB, Murray DM. Mild hypoxic ischaemic encephalopathy and long term neurodevelopmental outcome - A systematic review. Early Hum Dev. 2018 May;120:80-87. doi: 10.1016/j.earlhumdev.2018.02.007. Epub 2018 Feb 26.
- Background: PubMed 27650049Murray DM, O'Connor CM, Ryan CA, Korotchikova I, Boylan GB. Early EEG Grade and Outcome at 5 Years After Mild Neonatal Hypoxic Ischemic Encephalopathy. Pediatrics. 2016 Oct;138(4):e20160659. doi: 10.1542/peds.2016-0659. Epub 2016 Sep 20.
- Individual participant dataSharing planned: No. I am not authorized to share patient data.
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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.
3 sites 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 Mild, run by Uludag University at 3 sites 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 10 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salih Çağrı Çakır (+90 533 3453739, salihcagri@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological Outcomes in Neonates with Mild Hypoxic-ischemic Encephalopathy (time frame: at 18 and 24 months of age). 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 NCT07393620, which also lists 7 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 1 May 2026.