Comparison of Prone and Supine Positioning in the Immediate Postextubation Period of Preterm Infants: a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Successful extubation
研究概览
简要总结
The purpose of this study is to determine whether patient positioning (prone and supine positioning) contributes to the success of extubation in the immediate postextubation period of preterm infants.
详细描述
This study is double-blinded randomized controlled trial, whose aim is to compare the proportion of successful extubation of preterm infants immediately after the extubation. Methods: Participants will be recruited from neonatal intensive care unit (NICU) and they will be divided into two groups (supine and prone) and positioned in their respective groups after extubation. A clinical evaluation form and a parameters collection form (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature) will be used and filled before extubation and 48 hours after by the professional staff of the NICU. It will be considered a successful extubation all participants who staying extubated for 48 hours after extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns less than 37 weeks of gestation age (calculated by doctor using the method of Capurro/Ballard)
- •Newborns undergone to invasive mechanical ventilation in the first week of life, for more than 48 hours
排除标准
- •Newborns who present malformations and clinical or surgical conditions that preclude the positioning in prone or supine after extubation
结局指标
主要结局
Successful extubation
时间窗: 48 hours after extubation
次要结局
- Improvement of parameters(48 hours after extubation)
研究者
Maria Luiza Caires Comper
Master
Uniao Metropolitana de Educacao e Cultura