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NCT02260271 Clinical Trial

Florida Neonatal Neurologic Network

Hypoxic-Ischemic Encephalopathy Clinical Trial

— FN3  

Official title:
Florida Neonatal Neurologic Network

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02260271
Other study ID # IRB201501109
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 2011
Est. completion date December 2024

Study information
Verified date May 2023
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 3 Weeks
Eligibility 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))

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Database Entry/Biospecimen Collection
blood, urine, buccal samples and medical data collected

Locations
Country Name City State
United States University of Florida Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE) Measure HIE biomarker levels in blood samples obtained in infants born with HIE. 2 years
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