Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Increase in Muscle activity
研究概览
简要总结
To compare and analyze the effects on the electromyographic activity of preterm newborns placed in the hammock position with the activity of newborns not placed in this position.
详细描述
Randomized clinical trial, according to CONSORT standards, with newborn preterm gestational age <34 weeks and birth weight <1500 g, admitted to the intensive care unit. Newborns will be randomized. Those selected for the control group (CG) will be placed in the incubator following the service routine. Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments. The evaluation of muscle activity will be carried out through surface electromyography. Evaluations shall be performed immediately before the intervention; immediately after 24 hours of intervention; and within 24 hours without intervention, in order to compare the values before and after the intervention of the two groups, as well as if the effects of the intervention are maintained after its removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 20 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm Infants with gestational age <34 weeks
- •Free from mechanical ventilation in the last 48 hours prior to electromyographic evaluation
- •Not in use of supplemental oxygen at the time of assessment
排除标准
- •Apgar score of less than seven in the fifth minute
- •Previous history of perintraventricular hemorrhage grade III and / or IV
- •Congenital infection
- •Congenital heart defects
- •Neonatal Obstetric traumas
- •Gastroesophageal Reflux Disease
- •Genetic syndromes
- •Congenital malformations
- •Sepsis with meningitis
- •Orthopedic and musculoskeletal alterations
研究组 & 干预措施
Intervention Group (Hammock positioning)
Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments.
干预措施: Hammock positioning (Other)
Control Group
Those selected for the control group (CG) will be placed in the incubator following the service routine.
结局指标
主要结局
Increase in Muscle activity
时间窗: 24 hours
In preterm infants placed in hammocks with gestational age less than or equal to 34 weeks and birth weight less than or equal to 1500g: 1. Muscle activity of the elbow flexors (corresponding to the biceps muscle) and knee flexors (corresponding mainly to the hamstring muscle group) increases. 2. The increase in electromyographic activity persists 24 hours after removal of the intervention.
次要结局
未报告次要终点
研究者
Isabel Cristina de Almeida Eyre
Mrs
Instituto Materno Infantil Prof. Fernando Figueira