Hypoxic-Ischemic Encephalopathy Clinical Trial
Official title:
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (HIE).
NCT number | NCT02264808 |
Other study ID # | IRB201400699 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | December 3, 2018 |
Verified date | January 2020 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.
Status | Completed |
Enrollment | 21 |
Est. completion date | December 3, 2018 |
Est. primary completion date | December 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Months to 20 Months |
Eligibility |
Inclusion Criteria: - children already enrolled in IRB#504-2011 - 18-20 months of age Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bayley-III developmental assessment in children, with Hypoxic Ischemic Encephalopathy (HIE) diagnosis at birth, at 18-20 months of age | Compare Developmental Outcomes to HIE Biomarker concentrations at birth | 2 years |
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