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Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates

NCT07024771 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

  • Hypoxic Ischemic Encephalopathy (HIE)

Interventions

DEVICE

Automated Pupillometer

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

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Khorshid Mohammad, MD, MSc, FRCP, FRCPC · Cummings school of medicine, University of Calgary

Eligibility

Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07024771 on ClinicalTrials.gov