Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Abnormal EEG pattern — 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"

Trial sites (1)

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