Florida Neonatal Neurologic Network

N/AEnrolling By InvitationNCT02260271

University of Florida1,000 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Hypoxic-Ischemic Encephalopathy

Interventions

Database Entry/Biospecimen CollectionOTHER

blood, urine, buccal samples and medical data collected

Eligibility

Sex: ALLMin age: 1 DayMax age: 3 Weeks

Medical Language ↔ Plain English

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))

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)

Measure HIE biomarker levels in blood samples obtained in infants born with HIE.

Time frame: 2 years

Data from ClinicalTrials.gov

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