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- Klinische proef NCT02349672
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (HIE) 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 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Florida
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Gainesville, Florida, Verenigde Staten, 32610
- University of Florida
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Healthy Control
The healthy control group will have 500-800uL (less than 1 mL) of blood collected.
This sample will be obtained at the same time that the neonate is already having a standard blood screenings drawn at 24 and 48 hours of life.
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Blood will be collected to test for concentrations of UCH-L1 and GFAP.
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Clinical Control
The clinical control group will be healthy neonates that are being evaluated for jaundice, with multiple blood samples drawn between birth and 48 hours of life to monitor serum bilirubin.
With these already scheduled lab draws, we will draw an additional 0.8-1 mL of blood.
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Blood will be collected to test for concentrations of UCH-L1 and GFAP.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Levels of UCH-L1 in blood
Tijdsspanne: 72 hours
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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.
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72 hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Levels of GFAP in blood
Tijdsspanne: 72 hours
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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.
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72 hours
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Nicole R Copenhaver, RN, Study nurse UF Neonatology
- Studie stoel: Melissa Huene, RN, Study nurse UF Neonatology
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB201400671
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op blood sample
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