Florida Neonatal Neurologic Network
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/30/2019 |
| Start Date: | September 2011 |
| End Date: | January 2021 |
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.
encephalopathy (HIE). In addition, the following samples will be collected in a
bio-repository for future studies: blood, urine, and buccal samples.
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.
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.
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)
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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