Florida Neonatal Neurologic Network

• Conditions: Hypoxic-Ischemic Encephalopathy

• 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.

Study Timeline

• Study Start: 2011-09-01
• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-29
• Last Update Posted: 2025-10-03
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

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)

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States