Health TrialsbyHealthPanel

Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates

ConditionHypoxic Ischemic Encephalopathy (HIE)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 6
SponsorUniversity of Calgary

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Neonates ≥35 weeks of GA, with Hypoxic ischemic encephalopathy admitted to neonatal neuro-intensive care unit at Alberta children's hospital, Calgary will be included in the study

Disqualifiers

Infants with chromosomal abnormalities/ syndromic associations

Infants with ocular / orbital injuries or structural anomalies of the eye obscuring the pupillometry measurement

Infants with inadequate pupillometry data / EEG data

Trial population

Neonates ≥35 weeks of GA, with Hypoxic ischemic encephalopathy admitted to neonatal neuro-intensive care unit at Alberta children's hospital, Calgary

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Automated Pupillometer

    Device

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: HIE infants1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: