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NOT YET RECRUITING
NCT07024771

Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates

Sponsor: University of Calgary

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - 6 Hours

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2025-08

Completion Date

2026-06

Last Updated

2025-06-17

Healthy Volunteers

No

Interventions

DEVICE

Automated Pupillometer

An automated pupillometer will be used to measure pupil size and calculate NPi in newborns with HIE

Locations (1)

University of Calgary

Calgary, Alberta, Canada