Effect of Three-Stair-Position on Improvement of Apnea of Prematurity and Feeding Performance in Prematurity: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%
研究概览
简要总结
The purpose of this study is evaluating the effectiveness of three-stair-position (TSP) on the rate of Apnea of Prematurity (AOP), the feeding performance and the vital signs.
详细描述
Apnea of Prematurity (AOP) is common critical symptoms of preterm infants with great harm for prematurity. Recurrent apnea may lead to brain damage caused by hypoxia, affecting the nervous system, even threatening life (1, 2). Therefore, choosing an intervention which can prevent and reduce occurrence of AOP with fewer side effects is an important issue that should be closely watched by neonatal intensive care unit (NICU) health care.
Prone position is the forefront treatment due to its simple, economic and non-invasive. In clinic, it includes horizontal prone position (HPP), Head elevated tilt 15 ° prone position (HETP) and three-step-prone position (TSP)(3).Many studies have shown that HETP can allow thoracic volume increased and make abdominal movement more coordinated in preterm children, and then it is more favorable than the HPP on improving respiratory function. So HETP has been a routine position in NICU instead of HPP (4, 5). HETP, however, always make the babies slide to the foot of the bed resulting in airway obstruction. Therefore, scholars have proposed TSP which should prevent this phenomenon (6). In the study, the effectiveness of TSP on improvement of AOP will be evaluated trying to find a more suitable position for preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm, gestational age(GA) <34weeks determined by obstetric ultra-sonogram and clinical examination
- •steady vital signs
- •Apgar scores were greater than or equal to 3 at 1min and greater than or equal to 5 at 5 minutes.
排除标准
- •infants with congenital malformation，for example Congenital Heart Disease, Diaphragmatic hernia, Hirschsprung,etc
- •Infants who need special position and/or intervention (gastroschisis or umbilical catheterization)
- •weight<1000g
- •infants who were undertaking conventional invasive mechanical ventilation.
结局指标
主要结局
Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%
时间窗: 7 Days
The rate of AOP
时间窗: 7 Days
次要结局
- Adverse events during feeding(7 Days)
- respiratory rate(7 Days)
- Number of Participants with distension(7 Days)
- amount of retention milk(7 Days)
- SPO2(7 Days)
- Times of milk retention(7 Days)
- Heart rate(7 Days)
- Number of Participants with Adverse Events(7 Days)
- Number of Participants who need treatments(7 Days)