Hypoxic Ischemic Encephalopathy Clinical Trial
Official title:
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (HIE) Control Levels
NCT number | NCT02349672 |
Other study ID # | IRB201400671 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | July 2017 |
Verified date | June 2018 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Hypoxic-ischemic encephalopathy (HIE) is a serious birth complication due to systemic
asphyxia which occurs in about 20 of 1,000 full-term infants and nearly 60% of premature
newborns. Between 10-60% of babies who exhibit HIE die during the newborn period and up to
25% of the HIE survivors have permanent neurodevelopmental handicaps in the form of cerebral
palsy, mental retardation, learning disabilities, or epilepsy. HIE also has a significant
financial impact on the health care system. In the state of Florida, the total cost for
initial hospitalization is $161,000 per HIE patient admitted, but those costs don't take into
account the life-long costs.
Current monitoring and evaluation of HIE, outcome prediction, and efficacy of hypothermia
treatment rely on a combination of a neurological exam, ultrasound, magnetic resonance
imaging (MRI) and electroencephalography (EEG). However, these methods do a poor job in
identifying non-responders to hypothermia. MRI requires transport of the neonate with a
requisite 40-45 min scan, which is not appropriate for unstable neonates. Moreover, the
amplitude integrated EEG (aEEG), a common bedside monitoring technique currently used in
these patients to assess candidates and predict outcomes prior to hypothermia, can be
adversely affected by hypothermia itself and the patient may not appear to improve until
re-warming. Consequently, the development of a simple, inexpensive, non-invasive, rapid
biochemical test is essential to identify candidates for therapeutic hypothermia, to
distinguish responders from non-responders and to assess outcome. This research is the first
step needed to treat neonates with HIE employing a personalized medical approach using serum
proteins GFAP and UCH-L1 as biomarkers and by monitoring neonates responses to therapeutic
hypothermia. These biomarkers will aid in the direct care by providing a rapid test to
predict outcomes and select candidates who are likely to benefit from therapeutic hypothermia
and gauge a response to the neuroprotective intervention.
Status | Completed |
Enrollment | 39 |
Est. completion date | July 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 3 Days |
Eligibility |
Inclusion Criteria: - greater than 1.8 kg - gestational age of 34 weeks or greater Exclusion Criteria: - less than 1.8 kg - gestational age less than 34 weeks |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Levels of UCH-L1 in blood | Determining if UCH-L1 concentrations measured in neonates with HIE are significantly elevated as compared to controls. Evaluate serum biomarker concentrations from a cohort of neonatal HIE patients who are candidates for hypothermia. These samples will be compared to samples collected from the two cohorts of neonatal "control" subjects. | 72 hours | |
Secondary | Levels of GFAP in blood | Determining if GFAP concentrations measured in neonates with HIE are significantly elevated as compared to controls. Evaluate serum biomarker concentrations from a cohort of neonatal HIE patients who are candidates for hypothermia. These samples will be compared to samples collected from the two cohorts of neonatal "control" subjects. | 72 hours |
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