Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interaction and Social Cognition in Very Premature Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- interactions between parents and child
研究概览
简要总结
Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others.
Extreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment.
Early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.
详细描述
The aim of the study is to evaluate impact of a sensory-tonic stimulation on development of parent-infant interaction and on social cognition in very premature children.
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
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •very preterm child (born before 32 weeks of amenorrhoea)
- •parents agreeing to participate to the study
排除标准
- •child born before 25 weeks of amenorrhoea
- •child with a birth weight less than 600 grams
- •child with congenital malformation
- •child with hemodynamic instability
研究组 & 干预措施
Arm 1 : skin-to-skin contact associated with a sensory-tonic s
skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time
干预措施: sensory-tonic stimulation (Behavioral)
Arm 1 : skin-to-skin contact associated with a sensory-tonic s
skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time
干预措施: skin-to-skin contact (Behavioral)
Arm 2 : skin-to-skin contact only
skin-to-skin contact left free for parents
干预措施: skin-to-skin contact (Behavioral)
结局指标
主要结局
interactions between parents and child
时间窗: 12 months
Two free play sequences of 15 minutes will be filmed. The Coding Interactive Behavior (CIB; Feldman, 1998) contains 43 items (22 relating to parents, 16 relating to child and 5 related to parent-child dyad. Each item is rated from 1 (a little) to 5 (a lot). The Coding Interactive Behavior has 6 dimensions. The dimension "social commitment of the child" will be the primary outcome for this study.
次要结局
- Social cognition / Theory of mind(6 years)