- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- University of Florida
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Levels of UCH-L1 in blood
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Levels of GFAP in blood
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Nicole R Copenhaver, RN, Study nurse UF Neonatology
- Silla de estudio: Melissa Huene, RN, Study nurse UF Neonatology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Signos y Síntomas Respiratorios
- Hipoxia, Cerebro
- Isquemia cerebral
- Isquemia
- Enfermedades Cerebrales
- Hipoxia
- Hipoxia-Isquemia Cerebral
Otros números de identificación del estudio
- IRB201400671
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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