Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants
Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants After Birth: A Randomized Controlled Trial
Preterm infants frequently require non-invasive ventilation (NIV) to treat respiratory distress after birth. The effectiveness of NIV may be influenced by the interface used to deliver respiratory support. Nasal cannula and single nasal prong are two interfaces commonly used for NIV; however, evidence directly comparing their efficacy during the early postnatal period remains limited.
This randomized controlled trial aims to compare the efficacy of a nasal cannula and a single nasal prong as interfaces for non-invasive ventilation in preterm infants after birth. Eligible preterm infants requiring NIV after initial stabilization will be randomly assigned to receive respiratory support using either a nasal cannula or a single nasal prong. The assigned interface will be maintained for one hour following randomization, including during transport from the delivery room to the neonatal intensive care unit.
The primary outcome is the need for endotracheal intubation within one hour after interface application. Secondary outcomes include the need for endotracheal intubation within 6 hour of age, respiratory effectiveness, assessed by the oxygen saturation index (OSI) and arterial blood gas parameters (pH and partial pressure of carbon dioxide [pCO₂]), as well as interface-related adverse events, including interface dislodgement and nasal injury.
This study is expected to provide evidence to support the selection of an effective non-invasive ventilation interface for preterm infants after birth.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Número de teléfono: 085779153162
- Correo electrónico: adhitpi@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ina Rochayati
- Número de teléfono: 087712526805
- Correo electrónico: inarochayati@gmail.com
Ubicaciones de estudio
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia
- Rumah Sakit dr. Cipto Mangunkusumo
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Contacto:
- Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Número de teléfono: 085779153162
- Correo electrónico: adhitpi@gmail.com
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Contacto:
- Rochayati Ina
- Número de teléfono: 087712526805
- Correo electrónico: inarochayati@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Inclusion Criteria:
- Preterm infants with a gestational age of 28 to <37 weeks who develop respiratory distress and require non-invasive ventilation (NIV) after birth.
- Written informed consent is obtained from a parent or legal guardian.
Exclusion Criteria:
- Infants with congenital nasal defects, including cleft lip and palate.
- Infants with prenatally diagnosed congenital anomalies that contraindicate NIV, including congenital diaphragmatic hernia, choanal atresia, esophageal atresia with tracheoesophageal fistula, or congenital heart disease.
- Infants with multiple congenital anomalies.
- Infants requiring endotracheal intubation for positive pressure ventilation immediately after birth.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Arm 1 with arm label: Nasal Cannula
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Non-invasive ventilation delivered through a nasal cannula as the respiratory interface for one hour after randomization in preterm infants after birth.
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Comparador activo: Arm 2 with arm label: Single Nasal Prong
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Non-invasive ventilation delivered through a single nasal prong as the respiratory interface for one hour after randomization in preterm infants after birth.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The need for endotracheal intubation
Periodo de tiempo: Within 1 hour after interface application.
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The proportion of preterm infants requiring endotracheal intubation during the first hour after application of the assigned non-invasive ventilation interface.
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Within 1 hour after interface application.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The need for Endotracheal Intubation
Periodo de tiempo: By 6 hours of age
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The proportion of preterm infants requiring endotracheal intubation by 6 hours of age.
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By 6 hours of age
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Oxygen Saturation Index (OSI)
Periodo de tiempo: At 1 hour after interface application
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Oxygen saturation index measured to assess respiratory effectiveness after 1 hour application of the assigned non-invasive ventilation interface.
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At 1 hour after interface application
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Partial Pressure of Carbon Dioxide (pCO₂)
Periodo de tiempo: At 1 hour after interface application
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Partial pressure of carbon dioxide (pCO₂) measured to evaluate ventilatory effectiveness at 1 hour after application of the assigned non-invasive ventilation interface.
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At 1 hour after interface application
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Blood pH
Periodo de tiempo: At 1 hour after interface application
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Blood pH measured to evaluate oxygenation effectiveness at 1 hour after application of the assigned non-invasive ventilation interface.
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At 1 hour after interface application
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Interface Dislodgement
Periodo de tiempo: Within 1 hour after interface application
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The proportion of infants experiencing dislodgement of the assigned non-invasive ventilation interface during the first hour after interface application.
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Within 1 hour after interface application
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Title Nasal Injury
Periodo de tiempo: At 1 hour after interface application
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Description The proportion of infants developing nasal injury associated with the assigned non-invasive ventilation interface during the first hour after interface application.
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At 1 hour after interface application
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- 26-02-0251
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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