Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- cognitive scorer at two years corrected age
研究概览
简要总结
The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care (incubator) right after delivery. Preterm infants will be randomized to either intervention or standard care group. Data on body temperature, blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the infant will be video-recorded during the first 24 hours and at three months of age for analysis of the general movements.
详细描述
Power calculations are based on a difference in Bayley Scale of Infant Development III, cognitive scale at two years corrected age of about 7,5 mean score =0.5 SD (α=0,05, β=0.80). Based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. Allowing for withdrawals, the sample size is set to 68 in each group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)
排除标准
- •Infants who need immediate medical interventions
研究组 & 干预措施
skin-to-skin
immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.
干预措施: skin-to-skin (Behavioral)
standard care
after birth the baby is transferred to the neonatal intensive care unit
干预措施: standard care (Behavioral)
结局指标
主要结局
cognitive scorer at two years corrected age
时间窗: 2 year
measured by Bayley Scales of Infant Development Third Edition (BSID III)
次要结局
- change in heart rate(24 hours)
- change in body temperature(24 hours)
- change in blood glucose(24 hours)
- Nutrition(1 year)
- general movements (GM) at 3 months corrected age(3 months)
- Social/emotional competence at three months corrected age(3 months)
- Social/emotional competence at two years corrected age(2 years)
- Developmental skills at two years corrected age(2 years)
- Maternal anxiety(2 years)
- Child Behaviour(5 year)
- change in respiration frequency(24 hours)
- Social/emotional competence at two years corrected age(1 year)
- Developmental skills at two years corrected age(1 year)
- Maternal anxiety(at discharge from hospital)
- Maternal anxiety(3 months)