跳至主要内容
临床试验/NCT06458114
NCT06458114招募中不适用

Feeling of Caregivers After a Palliative Management in Delivery Room of Extreme Premature Babies Not Eligible for Intensive Care : a French Qualitative and Quantitative Monocentric Study.

CHU de Reims1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
CHU de Reims
入组人数
50
试验地点
1
主要终点
Assessment of caregiver feeling

研究概览

简要总结

Introduction :

The birth of a child is usually a happy event that caregivers working in delivery rooms share with families.

Unfortunately, newborns sometimes need palliative care as soon as birth occurs.

In France, neonates who were liveborn under 24+0 weeks amenorrhea (date of last mentrual period) or weighing less than 500 grams) usually have non resuscitation in delivery room [Ancel 2020]. Some of them are considered as viable (referring to World Health Organisation definition : either term ≥ 22 + 0 amenorrhea week or birth weight ≥ 500 grams), others as nonviable (term < 22 AW and birth weight ≤500 grams).

In France, legislative development over last two decades have allowed the emergence of palliative care in delivery room. In a French survey in 2016, 83% of maternities were confronted at least once a year with this situation.

详细描述

In France as in other countries, published studies concerning palliative care for extremely premature babies focused on the " grey zon " period, but not on the nonviable preterm infants (also called late miscarriage) who have signs of life at birth. Only a fairly recent French book of 735 pages exclusively dedicated to the palliative approach in perinatal medicine, reports in a single chapter the existence of palliative care in extremely non-viable premature newborns.

There is a paucity of articles about the actual experience of caregivers confronted to palliative care of extremely preterm babies, viable or non viable, primarily studies in the so-called "gray" literature. Thus, a midwifery graduation thesis describes the experience of midwives in a French university hospital following the care of babies born alive between 18 and 24 weeks old . Two recent reviews explore the notion of resilience of caregivers who have been involved in perinatal palliative care . A nursing graduation dissertation explores the emotions of caregivers faced with perinatal bereavement .

Primary objective: the primary objective of this both qualitative and quantitative monocentric study is to explore the feelings of caregivers (doctors, midwifes, nurse's aids, pediatric nurses) within 2 months of a palliative situation for an extremely preterm baby in a delivery room, viable or not, and not eligible for resuscitation.

Secondary objective: the secondary objective of the study is to quantify the impact of this stressful event:

  • Within the first month (acute stress).
  • 2 months after the event (post-traumatic stress).

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any caregiver working at the Universitary Hospital of Reims (France) (pediatrician, obstetrician, midwife, midwife, nurse's aide, pediatric nurse, midwife student, peidatrician student).
  • who cared for an extremely preterm newborn in a delivery room, with a palliative approach,
  • and gave his/her consent.
  • The baby must have shown at least minimal signs of vitality (that is : heartbeats, cry, respiratory movements, painful facies, gasps).
  • The caregiver must has been physically present with either the newbor, or the mother, or both.
  • Exclusion Criteria : none

排除标准

  • 未提供

结局指标

主要结局

Assessment of caregiver feeling

时间窗: 1 month

Semi-directional interviews will be carried out with the identification of the main themes during the verbatim transcription (qualitative study).

次要结局

  • Assessment of stress(2 months)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验