Florida Neonatal Neurologic Network
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Interventions
- Other: Database Entry/Biospecimen Collection
- Registration Number
- NCT02260271
- Lead Sponsor
- University of Florida
- 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 studies: blood, urine, and buccal samples.
- 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 with the data and samples will receive Institutional Review Board (IRB) approval.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- 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)
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Exclusion Criteria
- Presence of lethal chromosomal abnormalities
- Severe IUGR
- Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Database Entry/Biospecimen Collection Database Entry/Biospecimen Collection Medical information of infants born with HIE entered into RedCap database. In addition, Blood, urine, buccal samples will be collected.
- Primary Outcome Measures
Name Time Method Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE) 2 years Measure HIE biomarker levels in blood samples obtained in infants born with HIE.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States