Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
Nasal High-frequency Oscillatory Ventilation (NHFOV) vs Nasal Continuous Positive Airway Pressure(NCPAP) for Ventilated Newborn Infants With BPD: a Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Supplying with the combined advantages of NCPAP and high-frequency oscillatory ventilation (HFOV) with high carbon dioxide(CO2) removal, no need for synchronisation, non-invasion, less volume/barotraumas, and increased functional residual capacity, nasal HFOV(NHFOV) was considered as a strengthened version of NCPAP. Furthermore, the superimposed oscillations of NHFOV could avoid gas-trapping, and allowed to obviously up-regulate mean airway pressure (MAP) more than NCPAP. Thus, NHFOV might be more beneficial as post-extubation respiratory support strategy to avoid re-intubation and subsequent complications and/or sequelae as compared with NCPAP in preterm infants. Nowadays, NHFOV was increasingly used in neonatal intensive care unit (NICU) around the world due to its convenient operation. A retrospective review has reported the beneficial effects of NHFOV in preterm infants as a remedial measure after failing to other noninvasive modes, including reducing the number of apneas, bradycardias or oxygen desaturations. However, there were rare randomized controlled studies comparing NHFOV with NCPAP in preterm infants with BPD.
We have found that NHFOV is superior to NCPAP in avoiding re-intubation in very preterm infants with the first extubation. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support strategies on the need for endotracheal ventilation, as well as pressure of CO2(PCO2) level in preterm infants with BPD.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chen（陈） Long, MD, PhD
- Número de teléfono: +8613883559467
- Correo electrónico: neuroclong@126.com
Ubicaciones de estudio
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Chongqing
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Chongqing, Chongqing, Porcelana, 400014
- Reclutamiento
- Chen（陈）
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Contacto:
- Chen（陈） Long, MD,PhD
- Número de teléfono: +8613883559467
- Correo electrónico: neuroclong@126.com
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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:
Eligibility requirements for neonates:
- The gestational age is less than 32 weeks
- The preterm neonates are diagnosed with BPD and need invasive ventilation
- Extubation and subsequent noninvasive ventilation is ready to be carried out
Exclusion Criteria:
one of the following conditions is needed:
- there were no intraventricular hemorrhage(IVH) grades 3 or 4
- major congenital anomalies
- parents' decision not to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: NHFOV
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
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After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
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Comparador activo: NCPAP
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
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After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
re-intubation rate
Periodo de tiempo: seven days after extubation
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the newborn infants with ventilated BPD is reintubated after extubation
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seven days after extubation
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death
Periodo de tiempo: seven days after extubation
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the newborn infants with BPD die
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seven days after extubation
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the level of carbon dioxide
Periodo de tiempo: seven days after extubation
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the level of carbon dioxide is measure after extubation between groups
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seven days after extubation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
necrotizing entercolitis(NEC)
Periodo de tiempo: seven days after extubation
|
the newborn infants with BPD is diagnosed with NEC
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seven days after extubation
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intraventricular hemorrhage(IVH)
Periodo de tiempo: seven days after extubation
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the newborn infants with BPD is diagnosed with NEC
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seven days after extubation
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
Otros números de identificación del estudio
- NHFOV for sBPD
Información sobre medicamentos y dispositivos, documentos del estudio
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