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临床试验/NCT03004677
NCT03004677终止不适用

Effect of Skin-to-skin Contact on Interaction and Parents' Sleep

Linkoeping University3 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
11
试验地点
3
主要终点
Sleep quality

研究概览

简要总结

This study evaluates the effect of a late intervention of continuous skin-to-skin contact (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the intervention and the other half will receive standard care.

详细描述

The intervention is based on a method developed to facilitate closeness and human touch between parents and preterm infants in neonatal intensive care. Continuous skin-to-skin contact (SSC) means, in this study, that the late preterm infant is cared for skin-to-skin on the parents' chest, instead of in a heating-bed, 24 hours a day. The parents will take turns to care for the infant in SSC.

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

性别
All
接受健康志愿者

入选标准

  • Parents staying at the NICU with a single preterm infant born <33 weeks of gestation
  • The family should have been transferred to family-room from intensive care
  • Swedish speaking parents

排除标准

  • Infants with major congenital malformation,
  • Infants with intraventricular hemorrhage grade III-IV
  • Infants with chromosome defect that could affect the infant´s ability to interact.
  • Parents with sleeping disorder
  • Parents with psychiatric problem or drug use.

结局指标

主要结局

Sleep quality

时间窗: Day 1 to 5

sleep diary every day for five days

次要结局

  • Mood(day 2 to 5)
  • Bonding(Baseline and 1-3 days before planned discharge from the NICU.)
  • Depression(Baseline and 1-3 days before planned discharge from the NICU.)
  • Activity(Day 1-5)
  • Anxiety(Baseline and 1-3 days before planned discharge from the NICU.)

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

Associate professor

Linkoeping University

研究点 (3)

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