Florida Neonatal Neurologic Network

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.

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

1 day–3 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

Database Entry/Biospecimen Collection

Other

blood, urine, buccal samples and medical data collected

Primary outcomes

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

Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: FN3

Important dates

Study start: 2011
Primary completion: 2045
Study completion: 2045
First posted: Oct 9, 2014
Registry last updated: Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation