Clinical Trial

Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates

Study acronym: SHINE
Not Yet Recruiting
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Record status
This record was last updated June 17, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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). 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.
Trial Details
NCT Number NCT07024771
Lead Sponsor University of Calgary
Conditions Hypoxic Ischemic Encephalopathy (HIE)
Enrollment 25 participants
Start Date 2025-08
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-06-17