Hypoxic-Ischemic Encephalopathy
Conditions
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.
Interventions
blood, urine, buccal samples and medical data collected
Sponsors
University of Florida
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Weeks
Healthy volunteers
No
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))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael D Weiss, MD
University of Florida
Outcome results
None listed