- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02366715
Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research
IMLEMENTATION OF High Flow Nasal Cannulae Therapy FOR THE TREATMENT OF BRONCHIOLITIS IN A GENERAL PEDIATRIC WARD - A RETROSPECTIVE AND PROSPECTIVE CLINICAL TRIAL
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Supportive Care, Single Group Assignment, Open Label, Non-Randomized, Efficacy Study
The research is devised as follows:
Prospective section: We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents.
Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.
Retrospective section: We will examine up to 200 cases of children aged 0-2 years hospitalized due to Bronchiolitis in Pediatrics C during 2014-2016 which were not enrolled in our research (due to lack of consent/unavailable HHHFNC etc.). We will compare clinical data and vital parameters between the groups treated with HHHFNC and those who were not.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eran Rom, Dr.
- Número de teléfono: 00-972-3-9253775
- Correo electrónico: eranrom5@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Nimrod Sachs, Dr.
- Número de teléfono: 00-972-3-9253775
- Correo electrónico: nimrod_rod@yahoo.com
Ubicaciones de estudio
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Petah Tikva, Israel
- Reclutamiento
- Schneider Medical Center of Israel
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Contacto:
- Eran Rom, MD
- Número de teléfono: +972-54-770-5626
- Correo electrónico: Eranr2@clalit.org.il
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
in age interval, diagnosed with Bronchiolitis
Exclusion Criteria:
Chronic heart/lung disease, immunocompromised state
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: HeatedHumidifiedHighFlowNasalCannula
Treatment for moderate-severe cases of Bronchiolitis while monitoring medical parameters
|
We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co. [3] which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents. Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in Bronchiolitis Severity Score grade
Periodo de tiempo: during the 20-40 hours of the protocol
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The grade in the Bronchiolitis Severity Score (0-12) reflects a general improvement or deterioration in any of these 5 parameters - oxygen saturation, breath rate, general appearance, degree of dyspnea and lung auscultation result.
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during the 20-40 hours of the protocol
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
CO2 pressure
Periodo de tiempo: during the 20-40 hours of the protocol
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(in mmHg) measured by a transcutaneous sensor.
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during the 20-40 hours of the protocol
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Medical interventions
Periodo de tiempo: during the 20-40 hours of the protocol
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Any medication given to the child during the time of the protocol including IV fluids, inhalations, diuretics.
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during the 20-40 hours of the protocol
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Ability to take in food orally
Periodo de tiempo: during the 20-40 hours of the protocol
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Whether the child has been able to feed - yes or no.
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during the 20-40 hours of the protocol
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Number of Pediatric Intensive Care Unit (PICU) admissions
Periodo de tiempo: The whole hospitalization period of the child
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Whether the child needed admission to PICU
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The whole hospitalization period of the child
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eran Rom, Dr., Schneider Children Medical Center of Israel
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Estimar)
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
Otros números de identificación del estudio
- 0586-14-RMC
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