An observational study in Hypoxic Ischemic Encephalopathy (HIE), sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged Up to 6 Hours. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by University of Calgary · Observational
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Among 19 studies in Hypoxia-Ischemia, Brain with a site in Canada — 10 open to participants now, 10 under way, none of them phase 3. Hypoxia-Ischemia, Brain · Canada.
Among the 19 studies in Hypoxia-Ischemia, Brain with a site in Canada, this one is one of 4 that started in 2025, is one of 5 observational ones, and was the 16th registered.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
Browse Hypoxia-Ischemia, Brain studies →10 of the 19 studies in Hypoxia-Ischemia, Brain with a site in Canada are open now. Recruiting first, the newest first:
University of Alberta · Sites in Canada
Ages 1 days–1 days
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada
University of Calgary · Sites in Canada
Pia Wintermark · Sites in Canada, United States
Ages 0 min–48 hrs
Hamilton Health Sciences Corporation · Sites in Canada
Ages 1 days–15 days
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 60 Hypoxia-Ischemia, Brain studies recruiting now, 21 (35%) set no upper age limit and 37 (62%) stop at 75 or younger; 46 take children under 18; 7 take healthy volunteers.
This study: Up to 6 Hours · all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 25 is below the median of 89 across 92 observational studies indexed under Hypoxia-Ischemia, Brain.
Median enrollment 42 across the 14 interventional studies, 50 across the 5 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
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1 of 19 have an industry lead sponsor. The 10 most frequent:
University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
University of Calgary has 2 studies filed under Hypoxia-Ischemia, Brain — fewer than ten, so there is no comparison to draw.
2 of the studies in Hypoxia-Ischemia, Brain with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07829887University of CalgaryCerebral Oximetry in Management of Post Cardiac Arrest | 2027-02 |
| NCT06985290Ipsita GoswamiDexmedetomidine Versus Morphine During Cooling Therapy in Neonates | 2027-09-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 19 studies in Hypoxia-Ischemia, Brain with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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
Neonates ≥35 weeks of GA, with Hypoxic ischemic encephalopathy admitted to neonatal neuro-intensive care unit at Alberta children's hospital, Calgary
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Device: Automated Pupillometer
An automated pupillometer will be used to measure pupil size and calculate NPi in newborns with HIE
Also known as: Neurological pupil index
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"
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 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
Time frame: 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
Time frame: 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
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)
Plan to share: No — per data sharing restrictions , considering confidentiality of information, in a vulnerable population, IPD will not be shared
Start is estimated for Aug 2025; primary completion for Jun 2026, 10 months later.
Of 46 non-industry observational studies under Hypoxia-Ischemia, Brain, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20. This study's planned 10 months is below that.
Counting every sponsor, half of 50 studies reached it within 43 months; a quarter within 20.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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