Florida Neonatal Neurologic Network (FN3)

University of Florida

Status: Invitation-only

Conditions: Hypoxic-Ischemic Encephalopathy

Treatments: Other: Database Entry/Biospecimen Collection

Study type: Observational

Funder types: Other

Identifiers

NCT02260271

IRB201501109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 1 day to 3 weeks old

Volunteers: No Healthy Volunteers

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))

Trial design

1,000 participants in 1 patient group

Database Entry/Biospecimen Collection

Description:

Medical information of infants born with HIE entered into RedCap database. In addition, Blood, urine, buccal samples will be collected.

Treatment:

Other: Database Entry/Biospecimen Collection