The Effectiveness of Non-Invasive Ventilation Use in Preterm Infants.
Effectiveness of Synchronized Non-Invasive Ventilation to Prevent Invasive Mechanical Ventilation Use in Preterm Infants.
Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well as respiratory outcomes and possible secondary side effects.
SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
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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Madrid, España, 28033
- Cristina Ramos-Navarro
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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
Prospective observational study of SNIPPV use in preterm infants of less than 32 weeks of gestation from January 2012 to December of 2014.
SNIPPV is used for:
- nCPAP failure: Preterm infants supported with nCPAP that meet intubation criteria (FiO2>50%; apnea spells more than 4/h or more than 1 that needs PPV) if they are in a stable situation. SAP (systemic arterial pressure)> P10 with preserved respiratory drive (no more than 6 apneas episodes per hour or more than 2 requiring PPI).
Electively For extubation:
- Preterm infants in which nCPAP extubation has previously failed or Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
Descripción
Inclusion Criteria:
- Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied for nCPAP failure.
- Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied electively for extubation.
Exclusion Criteria: None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Preterm Infants treated with non-invasive ventilation
Preterm Infants of less than 32 weeks of Gestational age treated with synchronized non-invasive ventilation (SNIPPV) to prevent intubation or extubation failure based in a prospective protocol:
Preterm infants in which nCPAP extubation has previously failed or Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%). |
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Avoid of Invasive Mechanical Ventilation in the next three days.
Periodo de tiempo: through study completion, an average of 1 year
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The rate of infants treated with non-invasisive ventilation that do not need to be intubated in the next three days.
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through study completion, an average of 1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time on MV
Periodo de tiempo: through study completion, an average of 1 year
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Days on MV during hospitalitation
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through study completion, an average of 1 year
|
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Neurological impairment
Periodo de tiempo: through study completion, an average of 1 year
|
Intraventricular hemorrhage grade 3 or 4 (papile´s classification)
|
through study completion, an average of 1 year
|
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Rate of patients with air leaks
Periodo de tiempo: through study completion, an average of 1 year
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pulmonary air leak
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through study completion, an average of 1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cristina Ramos-Navarro, Gregorio Marañón Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Otros números de identificación del estudio
- 02/2015
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