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临床试验/NCT02034617
NCT02034617已完成不适用

Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care

Linkoeping University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
Cognitive abilities

研究概览

简要总结

When becoming a parent of a preterm infant there is an increased risk of stress. There are a number of studies showing that parental stress has a negative impact on their engagement with their child. Other studies, on the other hand, show that different intervention programs with the aim to strengthen the relationship can decrease parental stress and hence affect the parent-infant interaction in a positive way. Structured intervention programs for preterm infants have also been successful in improving the infants' cognitive functions.

The investigators have developed a program with the aim to strengthen the parent-infant interaction for late preterm infants. The observational program is called LiMoNid. Our hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them a deeper understanding of their child. They will hopefully develop more skills on how to communicate with their child; to see, interpret, understand and approach the child, which can lead to an improved parent-child interaction. Parental stress may also be reduced by increased understanding and control. Regarding the child itself, we hypothesize that the psychological development will be affected depending on the communication with the caregiver and depending on the support it has received in expressing its feelings and needs. The emotional regulation should be strengthened by such an intervention.

The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child interaction.

详细描述

The Design is a randomised controlled study in two groups; intervention group versus standard care. Parents who meet the inclusion criteria are given oral and written information about the study aim and procedure and are asked for participation. If the parents consent they will be randomised to one of two groups. Follow-ups will be conducted at 1 month, 4 months, 10-12 months corrected age and when the child is 4 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 96 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants born 30-36 weeks gestational age without known major malformations or complications
  • Families living in the county of Ostergotland, Sweden
  • Swedish speaking parents
  • Single or duplex birth

排除标准

  • Complications encountered during hospital stay that are known to affect cognition

结局指标

主要结局

Cognitive abilities

时间窗: 11 months

Bayley Scales of Infant Development

次要结局

  • Stress reactivity(1 month)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Evalotte Morelius

Professor

Linkoeping University

研究点 (2)

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