Florida Neonatal Neurologic Network

Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 out of 1000 births. HIE triggers an immediate neuronal and glial response.  Because of this destructive neuronal injury, up to 25% of neonates with moderate HIE and 100% of neonates with severe HIE exhibit severe permanent neuropsychological handicaps in the form of cerebral palsy, with or without associated mental retardation, learning disabilities, or epilepsy. The purpose of this study is to improve the outcome of neonates with brain injuries.

Detailed medical and sample database of infants born with hypoxic-ischemic encephalopathy (HIE) will be created. Both the medical information and the samples will be de-identified. In addition, the following samples will be collected in a bio-repository for future studies: blood, urine, and buccal samples.

The first portion of the analysis will focus of the heart rates and the correlation with the MRI obtained at 7-10 days of age. Correlations between the heart rate values and the MRIs will be made. The second goal of this proposed application is to determine if other vital signs patterns can predict outcomes.

 

Investigator(s):

Intervention(s):

  • Database Entry
  • Biospecimen Collection

 

Eligibility Criteria:


Study Population: Infants diagnosed with hypoxic-ischemic encepholopathy (HIE) at birth

Age Eligible: Up to 3 weeks od age

Sexes Eligible: All

 

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))

External Links


ClinicalTrials.gov