Hypoxic Ischemic Encephalopathy (HIE)SHINENCT07024771
Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates
An observational study of Hypoxic Ischemic Encephalopathy (HIE), run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this observational study is to learn if the reactivity of a newborn's eye to light (measured as an index, using a new device -pupillometer) reflect the health of their brain recovering from disruption of blood/oxygen supply during birth (Hypoxic Ischemic Encephalopathy-HIE). Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy (HIE)
- What is being tested?
- Automated Pupillometer
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2025to Jun 2026
- 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 Up to 6 hours
- All sexes
- No healthy volunteers
- Child
Study population: Neonates ≥35 weeks of GA, with Hypoxic ischemic encephalopathy admitted to neonatal neuro-intensive care unit at Alberta children's hospital, Calgary
Who may be able to join
- Neonates ≥35 weeks of GA, with Hypoxic ischemic encephalopathy admitted to neonatal neuro-intensive care unit at Alberta children's hospital, Calgary will be included in the study
Who cannot join
- Infants with chromosomal abnormalities/ syndromic associations
- Infants with ocular / orbital injuries or structural anomalies of the eye obscuring the pupillometry measurement
- Infants with inadequate pupillometry data / EEG data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Khorshid Mohammad, MD, Mac, FRCP, FRCPC contact
Canada1 site
University of Calgary
Calgary, Alberta, T2N1N4
Khorshid Mohammad, MD, MSc, FRCP, FRCPC, 587-893-0700, Khorshid.Mohammad@albertahealthservices.ca
Khorshid Mohammad, MD, MSc, FRCP, FRCPC
About this study
Official title: A Study On Association Between Neurological Pupil Index and Clinical Severity of Hypoxic Ischemic Encephalopathy In Neonates Admitted To Neonatal Neurocritical Care Unit
The goal of this observational study is to learn if the reactivity of a newborn's eye to light (measured as an index, using a new device -pupillometer) reflect the health of their brain recovering from disruption of blood/oxygen supply during birth (Hypoxic Ischemic Encephalopathy-HIE). The main questions it aims to answer are:
- With a decreasing reactivity index, does the chance of an abnormal electrical function of brain (noted by electroencephalography (EEG)) increase?
- With a decreasing reactivity index, do the odds of an indicator of severe impact on brain health (abnormal brain imaging, seizures, feeding difficulty) increase? Participants will undergo eye examination using the pupillometer instead of the regular penlight, as part of their routine neurological examination. This will not change the way in which the newborn is being treated and managed medically.
Read the detailed description
BACKGROUND:
A newborn baby diagnosed with Hypoxic ischemic encephalopathy (HIE) needs frequent assessment of brain function which includes assessment of pupils in the eyes. However the traditional penlight does not provide a standard measurement and is not very accurate , as it varies based on interpretation of the observer. A new hand-held, non-contact device known as the automated "pupillometer", not only provides a safe, reliable, accurate measurement of the pupil size, but also provides additional information like Neurological Pupil Index (NPi). This value is used to assess the brain function in adults and older children, but the significance of the same has not been studied in a newborn population.
METHODOLOGY:
An Informed consent will be obtained prior to enrolment of the infant in the study. Neurological examination and pupillary assessment will be done at 5 different timepoints: - first at admission(baseline), followed by 24 hours, 48 hours and 72 hours of life, and once prior to discharge. Measurements will be done in both eyes and lesser score of the two will be considered for analysis. Outcome measures including EEG (which is continuous) and MRI (done on day 5 per unit protocol) will be documented and collated for analysis. This is an observational study and the measurement of NPi will not alter the treatment protocol.
The device has been approved by Health Canada for use across all patient population. This device poses no new risks and is safe to use, as it is a non-contact device and is relatively easy to use. Aseptic precautions will be followed when the device is used.
ANALYSIS:
SAMPLE SIZE CONSIDERATIONS:
This is a novel study, with no pre-existing literature. Hence, an initial small scale pilot study will be undertaken with a convenient sample size of all moderate to severe HIE within a year, with anticipation of 70% recruitment. An estimated sample size of 20-25 will help estimate the effect size, variability of NPi, explore relationship between NPi \& indicators of severity of HIE and further refine study design \& sample size calculation
STATISTICAL ANALYSIS:
Primary outcome:
The primary outcome (abnormal EEG pattern) will be a categorical variable (Yes/No type) The relationship between NPi and the primary outcome will be analysed using logistic regression model and expressed as Odds ratio with 95% confidence intervals.
Secondary outcome:
The secondary outcome (a composite measure of factors which indicate risk for severe HIE (including occurrence of seizure during admission, abnormal MRI finding or persistent feeding difficulty) will be assessed using logistic regression A Receiver-Operator Characteristic curve analysis will evaluate the diagnostic accuracy of NPi in predicting clinical severity of HIE indicating sensitivity \& specificity. Any novel threshold values which can predict the cut-off for abnormal EEG pattern, or risk of severe HIE using other indicators will be identified with AUC >0.7
- Conditions
- Hypoxic Ischemic Encephalopathy (HIE)
- Being tested
- Automated Pupillometer
- Keywords
- Neurological pupil index, Hypoxic ischemic encephalopathy, automated pupillometry, neonatal neurocritical care, severity of HIE, therapeutic hypothermia, cooling therapy, NPi, seizures, EEG
- Medical subject headings
- Hypoxia-Ischemia, Brain, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated PupillometerDevice
Also called Neurological pupil index
An automated pupillometer will be used to measure pupil size and calculate NPi in newborns with HIE
| Study group | Role | What they receive |
|---|---|---|
| HIE infants | Newborns diagnosed with HIE , more than 35 weeks of age, admitted to a neonatal neurocritical care unit in Alberta Children's hospital, undergoing therapeutic hypothermia Receives: Device: Automated Pupillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal EEG pattern
Abnormal EEG patterns will be monitored via continuous amplitude -integrated EEG (aEEG) . It will be scored by an expert neonatal neurologist into an objective score ranging from 0 to 5, where 0 = normal, 1=discontinuous, 2= Burst suppression, 3= isoelectric, 4= seizures and 5= not done. Any score from 1 to 4 will be considered as indicative of severe HIE, and will be considered collectively as "abnormal EEG pattern"
Measured: From starting therapeutic hypothermia at admission (baseline) till completion of therapeutic hypothermia (72 hours from starting cooling therapy). EEG will be monitored CONTINUOUSLY during this period of 72 hours
Secondary outcomes (3)
Abnormal MRI findings
To identify any association between NPi and abnormal MRI brain findings
- MRI brain findings will be interpreted by an expert neuro-radiologist and classified based on modified WEEKE's score;
- any score >3 will be considered abnormal and indicate severe HIE
Measured: MRI brain will be done and scored between day 4 and day 5 from admission
Presence of seizure
To identify any association between NPi and occurrence of seizure during the hospital stay.
-Occurrence of seizure during the hospital stay will be monitored for and documented as YES/NO response based on presence or absence of seizure activity
Measured: baseline (day of admission) till day 5 after admission
persistent Feeding difficulty
To identify any association between NPi and persistent feeding difficulty at discharge.
- Persistent feeding difficulty will be defined as requiring tube feeds / home gavage feeds at the time of discharge
- will be documented as YES/NO response based on presence or absence of feeding difficulty
Measured: will be assessed at the time of discharge from NICU to home or transfer to ward (anytime between week 1 to week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
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 Encephalopathy (HIE)Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khorshid Mohammad, MD, MSc, FRCP, FRCPC, Principal investigator, Cummings school of medicine, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024771
- Sponsor's protocol ID
- REB25-0010
- Acronym
- SHINE
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: per data sharing restrictions , considering confidentiality of information, in a vulnerable population, IPD will not be shared
Publications
Oddo M, Sandroni C, Citerio G, Miroz JP, Horn J, Rundgren M, Cariou A, Payen JF, Storm C, Stammet P, Taccone FS. Quantitative versus standard pupillary light reflex for early prognostication in comatose cardiac arrest patients: an international prospective multicenter double-blinded study. Intensive Care Med. 2018 Dec;44(12):2102-2111. doi: 10.1007/s00134-018-5448-6. Epub 2018 Nov 26.
PubMed 30478620Riker RR, Sawyer ME, Fischman VG, May T, Lord C, Eldridge A, Seder DB. Neurological Pupil Index and Pupillary Light Reflex by Pupillometry Predict Outcome Early After Cardiac Arrest. Neurocrit Care. 2020 Feb;32(1):152-161. doi: 10.1007/s12028-019-00717-4.
PubMed 31069659Al-Obaidi SZ, Atem FD, Stutzman SE, Olson DM. Impact of Increased Intracranial Pressure on Pupillometry: A Replication Study. Crit Care Explor. 2019 Oct 30;1(10):e0054. doi: 10.1097/CCE.0000000000000054. eCollection 2019 Oct.
PubMed 32166235Kim TJ, Park SH, Jeong HB, Ha EJ, Cho WS, Kang HS, Kim JE, Ko SB. Neurological Pupil Index as an Indicator of Neurological Worsening in Large Hemispheric Strokes. Neurocrit Care. 2020 Oct;33(2):575-581. doi: 10.1007/s12028-020-00936-0.
PubMed 32096118Shah SS, Ranaivo HR, Mets-Halgrimson RB, Rychlik K, Kurup SP. Establishing a normative database for quantitative pupillometry in the pediatric population. BMC Ophthalmol. 2020 Mar 26;20(1):121. doi: 10.1186/s12886-020-01389-x.
PubMed 32216772Sandroni C, Citerio G, Taccone FS. Automated pupillometry in intensive care. Intensive Care Med. 2022 Oct;48(10):1467-1470. doi: 10.1007/s00134-022-06772-4. Epub 2022 Jun 30. No abstract available.
PubMed 35773500Jiang J, Sari H, Goldman R, Huff E, Hanna A, Samraj R, Gourabathini H, Bhalala U. Neurological Pupillary Index (NPi) Measurement Using Pupillometry and Outcomes in Critically Ill Children. Cureus. 2023 Oct 4;15(10):e46480. doi: 10.7759/cureus.46480. eCollection 2023 Oct.
PubMed 37927706Couret D, Boumaza D, Grisotto C, Triglia T, Pellegrini L, Ocquidant P, Bruder NJ, Velly LJ. Reliability of standard pupillometry practice in neurocritical care: an observational, double-blinded study. Crit Care. 2016 Mar 13;20:99. doi: 10.1186/s13054-016-1239-z.
PubMed 27072310Hall CA, Chilcott RP. Eyeing up the Future of the Pupillary Light Reflex in Neurodiagnostics. Diagnostics (Basel). 2018 Mar 13;8(1):19. doi: 10.3390/diagnostics8010019.
PubMed 29534018Brown KL, Agrawal S, Kirschen MP, Traube C, Topjian A, Pressler R, Hahn CD, Scholefield BR, Kanthimathinathan HK, Hoskote A, D'Arco F, Bembea M, Manning JC, Hunfeld M, Buysse C, Tasker RC. The brain in pediatric critical care: unique aspects of assessment, monitoring, investigations, and follow-up. Intensive Care Med. 2022 May;48(5):535-547. doi: 10.1007/s00134-022-06683-4. Epub 2022 Apr 21.
PubMed 35445823van Kooij BJ, van Handel M, Nievelstein RA, Groenendaal F, Jongmans MJ, de Vries LS. Serial MRI and neurodevelopmental outcome in 9- to 10-year-old children with neonatal encephalopathy. J Pediatr. 2010 Aug;157(2):221-227.e2. doi: 10.1016/j.jpeds.2010.02.016. Epub 2010 Apr 9.
PubMed 20381069Hagberg H, David Edwards A, Groenendaal F. Perinatal brain damage: The term infant. Neurobiol Dis. 2016 Aug;92(Pt A):102-12. doi: 10.1016/j.nbd.2015.09.011. Epub 2015 Sep 25.
PubMed 26409031
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study On Association Between Neurological Pupil Index and Clinical Severity of Hypoxic Ischemic Encephalopathy In Neonates Admitted To Neonatal Neurocritical Care Unit
- ClinicalTrials.gov ID
- NCT07024771
- Acronym / sponsor ID
- SHINE / REB25-0010
- Conditions
- Hypoxic Ischemic Encephalopathy (HIE)
- Keywords
- Neurological pupil index, Hypoxic ischemic encephalopathy, automated pupillometry, neonatal neurocritical care, severity of HIE, therapeutic hypothermia, cooling therapy, NPi
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 17 Jun 2025 (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.
The goal of this observational study is to learn if the reactivity of a newborn's eye to light (measured as an index, using a new device -pupillometer) reflect the health of their brain recovering from disruption of blood/oxygen supply during birth (Hypoxic Ischemic Encephalopathy-HIE). The main questions it aims to answer are:
- With a decreasing reactivity index, does the chance of an abnormal electrical function of brain (noted by electroencephalography (EEG)) increase?
- With a decreasing reactivity index, do the odds of an indicator of severe impact on brain health (abnormal brain imaging, seizures, feeding difficulty) increase? Participants will undergo eye examination using the pupillometer instead of the regular penlight, as part of their routine neurological examination. This will not change the way in which the newborn is being treated and managed medically.
Detailed description
BACKGROUND:
A newborn baby diagnosed with Hypoxic ischemic encephalopathy (HIE) needs frequent assessment of brain function which includes assessment of pupils in the eyes. However the traditional penlight does not provide a standard measurement and is not very accurate , as it varies based on interpretation of the observer. A new hand-held, non-contact device known as the automated "pupillometer", not only provides a safe, reliable, accurate measurement of the pupil size, but also provides additional information like Neurological Pupil Index (NPi). This value is used to assess the brain function in adults and older children, but the significance of the same has not been studied in a newborn population.
METHODOLOGY:
An Informed consent will be obtained prior to enrolment of the infant in the study. Neurological examination and pupillary assessment will be done at 5 different timepoints: - first at admission(baseline), followed by 24 hours, 48 hours and 72 hours of life, and once prior to discharge. Measurements will be done in both eyes and lesser score of the two will be considered for analysis. Outcome measures including EEG (which is continuous) and MRI (done on day 5 per unit protocol) will be documented and collated for analysis. This is an observational study and the measurement of NPi will not alter the treatment protocol.
The device has been approved by Health Canada for use across all patient population. This device poses no new risks and is safe to use, as it is a non-contact device and is relatively easy to use. Aseptic precautions will be followed when the device is used.
ANALYSIS:
SAMPLE SIZE CONSIDERATIONS:
This is a novel study, with no pre-existing literature. Hence, an initial small scale pilot study will be undertaken with a convenient sample size of all moderate to severe HIE within a year, with anticipation of 70% recruitment. An estimated sample size of 20-25 will help estimate the effect size, variability of NPi, explore relationship between NPi \& indicators of severity of HIE and further refine study design \& sample size calculation
STATISTICAL ANALYSIS:
Primary outcome:
The primary outcome (abnormal EEG pattern) will be a categorical variable (Yes/No type) The relationship between NPi and the primary outcome will be analysed using logistic regression model and expressed as Odds ratio with 95% confidence intervals.
Secondary outcome:
The secondary outcome (a composite measure of factors which indicate risk for severe HIE (including occurrence of seizure during admission, abnormal MRI finding or persistent feeding difficulty) will be assessed using logistic regression A Receiver-Operator Characteristic curve analysis will evaluate the diagnostic accuracy of NPi in predicting clinical severity of HIE indicating sensitivity \& specificity. Any novel threshold values which can predict the cut-off for abnormal EEG pattern, or risk of severe HIE using other indicators will be identified with AUC >0.7
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIE infants | – | Device: Automated PupillometerNewborns diagnosed with HIE , more than 35 weeks of age, admitted to a neonatal neurocritical care unit in Alberta Children's hospital, undergoing therapeutic hypothermia |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates ≥35 weeks of GA, with Hypoxic ischemic encephalopathy admitted to neonatal neuro-intensive care unit at Alberta children's hospital, Calgary
Key inclusion criteria (1 listed)
- Neonates ≥35 weeks of GA, with Hypoxic ischemic encephalopathy admitted to neonatal neuro-intensive care unit at Alberta children's hospital, Calgary will be included in the study
Key exclusion criteria (3 listed)
- Infants with chromosomal abnormalities/ syndromic associations
- Infants with ocular / orbital injuries or structural anomalies of the eye obscuring the pupillometry measurement
- Infants with inadequate pupillometry data / EEG data
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 |
|---|---|---|
| Automated PupillometerAlso: Neurological pupil indexAn automated pupillometer will be used to measure pupil size and calculate NPi in newborns with HIE | Device | HIE infants |
Primary outcome
Abnormal EEG pattern
Time frame: From starting therapeutic hypothermia at admission (baseline) till completion of therapeutic hypothermia (72 hours from starting cooling therapy). EEG will be monitored CONTINUOUSLY during this period of 72 hours
Abnormal EEG patterns will be monitored via continuous amplitude -integrated EEG (aEEG) . It will be scored by an expert neonatal neurologist into an objective score ranging from 0 to 5, where 0 = normal, 1=discontinuous, 2= Burst suppression, 3= isoelectric, 4= seizures and 5= not done. Any score from 1 to 4 will be considered as indicative of severe HIE, and will be considered collectively as "abnormal EEG pattern"
3 secondary outcomes
Abnormal MRI findings
Time frame: MRI brain will be done and scored between day 4 and day 5 from admission
Presence of seizure
Time frame: baseline (day of admission) till day 5 after admission
persistent Feeding difficulty
Time frame: will be assessed at the time of discharge from NICU to home or transfer to ward (anytime between week 1 to week 4)
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 17 Jun 2025.
- Results publication: PubMed 30478620Oddo M, Sandroni C, Citerio G, Miroz JP, Horn J, Rundgren M, Cariou A, Payen JF, Storm C, Stammet P, Taccone FS. Quantitative versus standard pupillary light reflex for early prognostication in comatose cardiac arrest patients: an international prospective multicenter double-blinded study. Intensive Care Med. 2018 Dec;44(12):2102-2111. doi: 10.1007/s00134-018-5448-6. Epub 2018 Nov 26.
- Results publication: PubMed 31069659Riker RR, Sawyer ME, Fischman VG, May T, Lord C, Eldridge A, Seder DB. Neurological Pupil Index and Pupillary Light Reflex by Pupillometry Predict Outcome Early After Cardiac Arrest. Neurocrit Care. 2020 Feb;32(1):152-161. doi: 10.1007/s12028-019-00717-4.
- Results publication: PubMed 32166235Al-Obaidi SZ, Atem FD, Stutzman SE, Olson DM. Impact of Increased Intracranial Pressure on Pupillometry: A Replication Study. Crit Care Explor. 2019 Oct 30;1(10):e0054. doi: 10.1097/CCE.0000000000000054. eCollection 2019 Oct.
- Results publication: PubMed 32096118Kim TJ, Park SH, Jeong HB, Ha EJ, Cho WS, Kang HS, Kim JE, Ko SB. Neurological Pupil Index as an Indicator of Neurological Worsening in Large Hemispheric Strokes. Neurocrit Care. 2020 Oct;33(2):575-581. doi: 10.1007/s12028-020-00936-0.
- Results publication: PubMed 32216772Shah SS, Ranaivo HR, Mets-Halgrimson RB, Rychlik K, Kurup SP. Establishing a normative database for quantitative pupillometry in the pediatric population. BMC Ophthalmol. 2020 Mar 26;20(1):121. doi: 10.1186/s12886-020-01389-x.
- Results publication: PubMed 35773500Sandroni C, Citerio G, Taccone FS. Automated pupillometry in intensive care. Intensive Care Med. 2022 Oct;48(10):1467-1470. doi: 10.1007/s00134-022-06772-4. Epub 2022 Jun 30. No abstract available.
- Results publication: PubMed 37927706Jiang J, Sari H, Goldman R, Huff E, Hanna A, Samraj R, Gourabathini H, Bhalala U. Neurological Pupillary Index (NPi) Measurement Using Pupillometry and Outcomes in Critically Ill Children. Cureus. 2023 Oct 4;15(10):e46480. doi: 10.7759/cureus.46480. eCollection 2023 Oct.
- Results publication: PubMed 27072310Couret D, Boumaza D, Grisotto C, Triglia T, Pellegrini L, Ocquidant P, Bruder NJ, Velly LJ. Reliability of standard pupillometry practice in neurocritical care: an observational, double-blinded study. Crit Care. 2016 Mar 13;20:99. doi: 10.1186/s13054-016-1239-z.
- Results publication: PubMed 29534018Hall CA, Chilcott RP. Eyeing up the Future of the Pupillary Light Reflex in Neurodiagnostics. Diagnostics (Basel). 2018 Mar 13;8(1):19. doi: 10.3390/diagnostics8010019.
- Results publication: PubMed 35445823Brown KL, Agrawal S, Kirschen MP, Traube C, Topjian A, Pressler R, Hahn CD, Scholefield BR, Kanthimathinathan HK, Hoskote A, D'Arco F, Bembea M, Manning JC, Hunfeld M, Buysse C, Tasker RC. The brain in pediatric critical care: unique aspects of assessment, monitoring, investigations, and follow-up. Intensive Care Med. 2022 May;48(5):535-547. doi: 10.1007/s00134-022-06683-4. Epub 2022 Apr 21.
- Results publication: PubMed 20381069van Kooij BJ, van Handel M, Nievelstein RA, Groenendaal F, Jongmans MJ, de Vries LS. Serial MRI and neurodevelopmental outcome in 9- to 10-year-old children with neonatal encephalopathy. J Pediatr. 2010 Aug;157(2):221-227.e2. doi: 10.1016/j.jpeds.2010.02.016. Epub 2010 Apr 9.
- Results publication: PubMed 26409031Hagberg H, David Edwards A, Groenendaal F. Perinatal brain damage: The term infant. Neurobiol Dis. 2016 Aug;92(Pt A):102-12. doi: 10.1016/j.nbd.2015.09.011. Epub 2015 Sep 25.
- NeurOptics: NPI-200 Pupillometer. Instructions for use . (2021).Link provided by the sponsor.
- Individual participant dataSharing planned: No. per data sharing restrictions , considering confidentiality of information, in a vulnerable population, IPD will not be shared
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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.
Khorshid Mohammad, MD, Mac, FRCP, FRCPC contact
Khorshid Mohammad, MD, MSc, FRCP, FRCPC principal investigator
Cummings school of medicine, University of Calgary
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 (HIE), run by University of Calgary at 1 site in Canada.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Jun 2025. 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 Canada. 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 Khorshid Mohammad, MD, Mac, FRCP, FRCPC (587-893-0700, Khorshid.Mohammad@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal EEG pattern (time frame: From starting therapeutic hypothermia at admission (baseline) till completion of therapeutic hypothermia (72 hours from starting cooling therapy). EEG will be monitored CONTINUOUSLY during this period of 72 hours). 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 NCT07024771, 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 17 Jun 2025.