- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Florida
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Gainesville, Florida, Forente stater, 32610
- University of Florida
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Levels of UCH-L1 in blood
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Levels of GFAP in blood
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Nicole R Copenhaver, RN, Study nurse UF Neonatology
- Studiestol: Melissa Huene, RN, Study nurse UF Neonatology
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB201400671
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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