- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Florida
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Gainesville, Florida, Förenta staterna, 32610
- University of Florida
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
|
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.
|
Blood will be collected to test for concentrations of UCH-L1 and GFAP.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Levels of UCH-L1 in blood
Tidsram: 72 hours
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Levels of GFAP in blood
Tidsram: 72 hours
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Nicole R Copenhaver, RN, Study nurse UF Neonatology
- Studiestol: Melissa Huene, RN, Study nurse UF Neonatology
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB201400671
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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