Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Heart rate and breathing rate will be decreased compared to baseline measurement.
研究概览
简要总结
Randomized crossover clinical trial in which is intended to assess the effect of facilitated tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale stress (ALPS-Neo) be observed before, during and one hour after the weight, and compared with normal practice, without facilitated tucking device.
详细描述
Population(n): 20 newborn When a patient is a possible candidate, consent will be asked their parents. After obtaining informed consent signed by parents, it will be assigned a random group (G1, G2). In the G1, the first weight without facilitated tucking device and the next day with facilitated tucking device will be held. G2 will be done in reverse.
Handling pre phase (T0): at least 20 minutes before vitals heart rate and respiratory rate are taken in five times.
handling phase (T1): 1. the facilitated tucking device is placed. 2. will wait five minutes and weight will be held in the incubator;at the time of leaving it in the incubator the same constants are taken.
post handling phase (T2): the same constants are taken one hour after such manipulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Days 至 9 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≤1500 grams newborns
- •a week of life about
排除标准
- •Hemodynamic instability requiring vasoactive drugs
- •Phototherapy at the time of the procedure
- •Congenital anomalies.
研究组 & 干预措施
facilitated tucking device (FTD)
20 infants use a FTD in the procedure of daily weight
干预措施: Facilitated tucking device (Procedure)
without FTD
20 infants use not a FTD in the procedure of daily weight
结局指标
主要结局
Heart rate and breathing rate will be decreased compared to baseline measurement.
时间窗: one year
Heart rate (beats / minute)and respiratory rate will decrease significantly during facilitated tucking weight.
次要结局
- Behavioral signs(one year)