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Clinical Trials/NCT03835039
NCT03835039
Terminated
Not Applicable

The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy

Albany Medical College1 site in 1 country101 target enrollmentJanuary 3, 2019
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ConditionsHIE - Perinatal Hypoxic - Ischemic Encephalopathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIE - Perinatal Hypoxic - Ischemic Encephalopathy
Sponsor
Albany Medical College
Enrollment
101
Locations
1
Primary Endpoint
Neurodevelopment at 2 years of age
Status
Terminated
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.

Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
January 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Infants with diagnosis at birth of HIE

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Neurodevelopment at 2 years of age

Time Frame: 2 years

Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.

MRI findings of encephalopathy

Time Frame: 6 days

MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.

Study Sites (1)

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