跳至主要内容
临床试验/NCT07237360
NCT07237360尚未招募不适用

Impact in Pediatric Emergency Departments of a Systematic Individualized Interview Conducted by an Advanced Practice Nurse, on the Prevention of Safe Sleeping and Unexpected Infant Death, in a Population of Infants From 0 to 6 Months

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月30日最近更新:
适应症

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
Increase in the number of babies lying well on their backs after the guided interview VS the number of babies lying well on their backs before the guided interview

研究概览

简要总结

The sudden unexpected infant death (SUID) is defined as "the sudden death of a child aged from 1 month to 1 year who had been healthy until then, whereas nothing in his known history or in the history of events could have allowed him to predict". In France, the French High Autority of Health (Haute Autorité de Santé (HAS)) has set the upper age limit at 2 years.

According to french statistics, between 250 and 350 babies die each year of unexpected infant death. It is the leading cause of infant mortality in developed countries, with all the devastating psychological, social and legal consequences for families. The national prevention campaigns for the "back to sleep" SUID carried out in the 1990s allowed a 75% decrease in the number of SUID. Yet, still at the moment, around 150 deaths could be avoided each year in France by respecting strict dorsal sleeping recommendations and a safe environment.

According to the SUID register of Nantes (France) of April 2024, 75% of deaths occur before the child's six months. The risk factors are mainly prematurity, exposure to tobacco (during and after pregnancy), and a sleeping mode not recommended by HAS. Indeed, on the day of death, 20% of babies were lying on their stomach or side, 30% shared their bed and 59% were lying in bedding at risk of containment or obstruction of the upper airway.

According to the database of National Association of Infant Death Unexpected Reference Centers since 2022, there has been a resurgence in the number of these deaths. This proves the urgency of prevention on this public health issue.

In parallel, we do not know why the number of SUID is not decreasing in correlation with the decrease in the birth rate in France. Moreover, it would be interesting to know the reasons why parents do not follow the recommendations of the HAS for their baby to sleep safely.

Thus, I wish to evaluate the impact of systematic prevention by the Advanced Practice Nurse with the parents of infants aged 0 to 6 months presenting to the Pediatric Emergency and know their barriers/levers to change.

My research question is therefore titled:

Why and how many infants under 6 months sleep in insecurity compared to lying babies according to the international recommendations ?

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
0 Months 至 6 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •All parents consulting the Pediatric Emergency Department of University Hospital of Angers for their baby aged 0 to 6 months

排除标准

  • •Any other person consulting for a baby aged 0 to 6 months who is not the parent of the baby: a grandparent, an uncle, an aunt, a childminder, the nursery manager, a friend of the parents, etc.
  • •Parent refusing the use of their data
  • •Parent and/or child under legal protection
  • •Parent who does not understand French

结局指标

主要结局

Increase in the number of babies lying well on their backs after the guided interview VS the number of babies lying well on their backs before the guided interview

时间窗: During the interview of the family, about 1 hour

次要结局

未报告次要终点

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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