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临床试验/NCT04034719
NCT04034719已完成不适用

Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home(PAPSE)

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Number of minuts with portage skin-to-skin

研究概览

简要总结

Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world.

In University hospital of Saint-Etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. Professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.

详细描述

This study it's a single-center, prospective, randomized study to evaluate the benefit of the scarf in the practice of skin-to-skin and portage (PAPSE Group) compared to a Skin-to-Skin and Carry Without Scarf (PAP group).

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
None

入排标准

年龄范围
— 至 10 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • For the child:
  • Any newborn regardless of gestational age and postnatal age hospitalized in the neonatology department of the University Hospital of Saint-Etienne
  • For the parent (father or mother):
  • Be a parent of a child eligible for the research protocol

排除标准

  • For the child:
  • Need for sedation or analgesia for the duration of the study
  • Orthopedic pathology incompatible with the practice of carrying
  • Other medical contraindications to carriage
  • Absence of parents
  • For the parent (father or mother):
  • Family, social or psychological situation compromising the evaluation
  • No fluency in the French language

结局指标

主要结局

Number of minuts with portage skin-to-skin

时间窗: From inclusion to 2 months after exit

Measured in minutes by the time sheet of presence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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