Impact of Parental Presence at the Ethics Meeting in Neonatal Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Parents' understanding of the medical decision made for their child following the ethics meeting.
研究概览
简要总结
In neonatal intensive care, physicians are sometimes confronted with decisions to withhold or withdraw life-sustaining treatment for a critically ill newborn. In France, these decisions are made by the medical team through a formal collegial ("ethics") meeting. Parents are not legally required to take part in this meeting, and their participation remains very rare at the national level.
Since 2018, the neonatal intensive care unit of Hopital NOVO (Nord Ouest Val d'Oise) (Pontoise site) has systematically offered parents the possibility of attending the collegial ethics meeting concerning their child when withholding or withdrawal of treatment is being considered. This study aims to evaluate the value of parental presence at the ethics meeting in helping parents understand the medical decisions made for their newborn.
This is a retrospective, single-centre, non-interventional, qualitative study based on a questionnaire developed specifically for this purpose, in the absence of any validated tool. Parents of newborns for whom an ethics meeting was held between 1 January 2018 and 31 December 2025 are invited to share their experience. Two questionnaire versions are used, one for parents who attended the meeting and one for parents who did not, allowing comparison between the two situations. The questionnaire explores parents' understanding of the decision, the emotional impact of the meeting, their sense of guilt and their acceptance of the decision.
Main hypothesis: parental participation in the ethics meeting promotes a better understanding of the medical decision, reduces feelings of guilt, and improves parents' long-term emotional experience.
详细描述
End-of-life decisions account for a substantial proportion of deaths in neonatal intensive care units, exceeding 70% in some cohorts in Europe and North America. These decisions are most often made following a multidisciplinary collegial decision-making process.
In France, the legal framework (Loi Leonetti 2005, reinforced by Loi Claeys-Leonetti 2016) is based on the principles of non-obstination déraisonnable and proportionality of care. This framework does not require the formal presence of parents during collegial meetings.
International literature on shared decision-making is associated with improved parental outcomes. A French multicenter study (Caeymaex et al., 2013) reported that parental involvement in end-of-life decisions was associated with lower rates of complicated grief, including reduced feelings of guilt and exclusion.
Despite this, formal parental participation in collegial meetings remains uncommon in France, in the context of prevailing models of care and concerns regarding parental emotional burden.
Since 2018, the neonatal intensive care unit at Hôpital NOVO has offered parents the option to attend collegial meetings. This process includes prior preparation by the attending physician, who clarifies that final medical responsibility remains with the healthcare team, as well as optional psychological support before and/or after the meeting.
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
- 否
入选标准
- •Adult parent (≥18 years)
- •Parent of a newborn for whom an ethics meeting was organized within the neonatal intensive care unit of Hôpital NOVO - Pontoise site
- •Ethics meeting organized between 01/01/2018 and 31/12/2025
排除标准
- •Refusal to participate in the study (refusal to complete the questionnaire and refusal to allow use of the child's medical record data)
- •Parent with a major inability to understand the study (severe cognitive impairment)
- •Parent not understanding French and therefore unable to complete the questionnaire
结局指标
主要结局
Parents' understanding of the medical decision made for their child following the ethics meeting.
时间窗: Questionnaire completion (15 minutes per parent)
Self-reported understanding assessed with the study-specific questionnaire (items 14, 15, 16 and 17 for parents who attended the meeting; items 6, 7, 10 and 14 for parents who did not attend), with responses rated on a 1-5 Likert scale (1 = not all, 5 = completely).
次要结局
- Overall emotional experience of the ethics meeting(Questionnaire completion (15 minutes per parent))
- Parental attendance rate at the ethics meeting(Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/2025)
- Mortality rate of newborns for whom an ethics meeting was organized.(Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/2025)
- Parental feeling of guilt regarding the decision(Questionnaire completion (15 minutes per parent))
- Parental acceptance of the decision made by the medical team.(Questionnaire completion (15 minutes per parent))