Status:
ENROLLING_BY_INVITATION
Florida Neonatal Neurologic Network
Lead Sponsor:
University of Florida
Conditions:
Hypoxic-Ischemic Encephalopathy
Eligibility:
All Genders
1-3 years
Brief Summary
Create a database with selected medical information on infants born with hypoxic-ischemic encephalopathy (HIE). In addition, the following samples will be collected in a bio-repository for future stud...
Detailed Description
The purpose of this study is to create a detailed medical and sample database of infants born with HIE. Both the medical information and the samples are de-identified. Any future studies performed wit...
Eligibility Criteria
Inclusion
- Gestational Age greater than or equal to 35 weeks gestation
- 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
- Presence of lethal chromosomal abnormalities
- Severe IUGR
- Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT02260271
Start Date
September 1 2011
End Date
December 1 2025
Last Update
October 3 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610