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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Número de telefone: 085779153162
- E-mail: adhitpi@gmail.com
Estude backup de contato
- Nome: Ina Rochayati
- Número de telefone: 087712526805
- E-mail: inarochayati@gmail.com
Locais de estudo
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonésia
- Rumah Sakit dr. Cipto Mangunkusumo
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Contato:
- Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Número de telefone: 085779153162
- E-mail: adhitpi@gmail.com
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Contato:
- Rochayati Ina
- Número de telefone: 087712526805
- E-mail: inarochayati@gmail.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The need for endotracheal intubation
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The need for Endotracheal Intubation
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-02-0251
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