Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1000 participants
OBSERVATIONAL
2011-09-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Database Entry/Biospecimen Collection
Medical information of infants born with HIE entered into RedCap database. In addition, Blood, urine, buccal samples will be collected.
Database Entry/Biospecimen Collection
blood, urine, buccal samples and medical data collected
Interventions
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Database Entry/Biospecimen Collection
blood, urine, buccal samples and medical data collected
Eligibility Criteria
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Inclusion Criteria
* Birth weight greater than or equal to 1.8 kg
* Less than or equal to 6 hours since insult occurred
* Severe hypoxic-ischemic encepholopathy (HIE)
Exclusion Criteria
* Severe IUGR
* Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))
1 Day
3 Weeks
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Michael D Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB201501109
Identifier Type: -
Identifier Source: org_study_id
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