Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants After Birth: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The need for endotracheal intubation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Minutes 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The need for endotracheal intubation
时间窗: Within 1 hour after interface application.
The proportion of preterm infants requiring endotracheal intubation during the first hour after application of the assigned non-invasive ventilation interface.
次要结局
- The need for Endotracheal Intubation(By 6 hours of age)
- Oxygen Saturation Index (OSI)(At 1 hour after interface application)
- Partial Pressure of Carbon Dioxide (pCO₂)(At 1 hour after interface application)
- Blood pH(At 1 hour after interface application)
- Interface Dislodgement(Within 1 hour after interface application)
- Title Nasal Injury(At 1 hour after interface application)
研究者
Adhi Teguh Perma Iskandar, Sp
Consultant Neonatologist
Indonesia University