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临床试验/NCT03403894
NCT03403894已完成不适用

Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年11月10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
35
试验地点
1
主要终点
Presence of respiratory movements and/or gasps

研究概览

简要总结

Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most cases, a child born before 24 years of age is stillborn, but in about one in three cases, it shows signs of life such as heartbeat, breathing, gasps or limb movements.

With these too small children showing signs of life, three attitudes are possible: doing nothing and waiting for this life to stop by themselves, setting up palliative care to ensure the child's comfort, or administering a medication to shorten his or her life. The attitude to have is not univocal and the feeling of the teams confronted with their management is difficult even if the goal of the caregivers is always to act as best as possible.

The main objective of the study is to describe the clinical state of the child and the practices implemented in the birth room at the Nice University Hospital when children showing signs of life before 24 weeks of amenorrhea are born.

The secondary objective is to describe caregivers' experiences, their experiences of these situations and attitudes towards children and their parents, and to identify ethical dilemmas in these situations.

This study is an observational cohort study including all births of live children before 24 weeks of amenorrhea at Nice University Hospital for 12 months. It consists of two parts: a quantitative study describing the child's condition and caregiving practices, and a qualitative study of caregivers' experiences and the determinants of their attitudes towards the child.

The investigator will coordinate the collection of the data necessary to conduct the quantitative study, and then conduct individual semi-directive interviews with each of the caregivers present at the birth of the child. The qualitative study will be based on the analysis of these interviews.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Child born before 24 weeks of amenorrhea (term estimated by echographic dating or by the date of the last menstrual period in the absence of ultrasound)
  • Inscription in the birth register (so from 15 weeks of amenorrhea)
  • Non-opposition of the parents

排除标准

  • Child transferred to neonatal intensive care unit.

结局指标

主要结局

Presence of respiratory movements and/or gasps

时间窗: 5 hours

Existence of limb movements

时间窗: 5 hours

Existence of cardiac activity

时间窗: 5 hours

Place of care

时间窗: 5 hours

Conditions of installation of the child (position, skin-to-skin...)

时间窗: 5 hours

Identification of the function of the caregiver(s) who performed the care

时间窗: 5 hours

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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