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Enrolling by invitation NCT02260271

Florida Neonatal Neurologic Network

— Observational Hypoxic-Ischemic Encephalopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Database Entry/Biospecimen Collection.
Who it may be relevant to
Registry conditions: Hypoxic-Ischemic Encephalopathy. Basic parameters: 1 Day — 3 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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.

Interventions

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

Primary outcome measures

  • Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE) [Time frame: 2 years]

Eligibility criteria

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))

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • University of Florida — Gainesville

Identifiers

NCT: NCT02260271 · IRB201501109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗