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NCT02349672 · ClinicalTrials.gov registry record
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 39
- Enrollment target
NCT02349672 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 39 participants.
The verdict
NCT02349672 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 39 participants
- Enrollment target
Study Summary
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
Interventions
- PROCEDURE blood sample
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02349672
The ClinicalTrials.gov registry entry for NCT02349672 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which blood sample is the first listed.
NCT02349672 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02349672 about?
NCT02349672 is a clinical study titled "Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)". 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 perm...
What is the current status of trial NCT02349672?
This trial is currently completed. The enrollment target is 39 participants. The study started on 2016-03. Estimated completion is 2017-07.
What interventions are being tested in trial NCT02349672?
The interventions under investigation include: blood sample (PROCEDURE).
Who is sponsoring clinical trial NCT02349672?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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