Variation of Salivary Oxytocin and Cortisol Levels in Premature Neonates and Their Mothers in Response to Multi-sensory Stimuli
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Oxytocin/cortisol ratio
研究概览
简要总结
The aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of premature neonates and their mother after sensorial stimuli.
详细描述
The aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of neonates with gestational age ranging from 32 to 34 completed weeks and in the saliva of their mothers. The measurements are taken before and after sensorial stimuli including mother voice exposure +/- tactile distraction for 10 minutes. The two interventions are performed between day 5 and day 12 after birth and 24 to 48 hours apart. Each child is randomised in a group depending on order of the two interventions.
Investigators hypothesize that an increase in the oxytocin/cortisol ratio will be occurred in neonates after hearing their mothers and that simultaneous tactile stimulation will mitigate that effect.
Concomitantly, the neonate's vital signs and his facial expressions are recorded during interventions. The mothers anxiety level is assessed PSS-NICU questionnaire given before the first and after the second intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 32 Weeks 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn gestational age 32 0/7 weeks to 34 6/7 weeks
- •Born at university hospital Geneva
- •French speaking parents
- •Out of incubator
- •Signed consent
排除标准
- •Newborn with one of the above conditions:
- •Congenital malformation
- •intraventricular hemorrhage grade III or IV
- •white matter abnormality
- •anti-epileptic or sedative drugs
- •altered consciousness level
- •Infant requiring respiratory support
- •psychiatric disorders in the mother or antenatal use of psychoactive drugs
- •Bilateral absent otoacoustic emissions and/or auditory evoked potential
- •Parents refusal to participate
结局指标
主要结局
Oxytocin/cortisol ratio
时间窗: at baseline and 10 minutes after intervention
Change in salivary oxytocin/cortisol ratio in response to the intervention
次要结局
- mother anxiety and mother infant bond(at baseline and 10 minutes after intervention)
- Facial expression analysis(at baseline, during and 10 minutes after intervention)
- Vital signs(at baseline, during and 10 minutes after intervention)
研究者
Prof. Olivier BAUD, MD-PhD
Professor
University Hospital, Geneva