Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458114
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-10
Brief Title:
Feeling of Caregivers After a Palliative Management of Extreme Premature Babies in Delivery Room
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 240 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
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 240 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
Detailed Description:
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 nurses 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
Expected impact of the study
These care situations are not described in the scientific literature and little described in the so-called grey literature this study aims to make them readable
The caregivers feelings and the mechanisms that underlie them may differ depending on the type of profession and links within a team this study aims to better characterize and understand them
As a result the investigators hope this study will identify avenues for work and action to better support caregivers and prevent work-related burnout
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 nurses 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
Expected impact of the study
These care situations are not described in the scientific literature and little described in the so-called grey literature this study aims to make them readable
The caregivers feelings and the mechanisms that underlie them may differ depending on the type of profession and links within a team this study aims to better characterize and understand them
As a result the investigators hope this study will identify avenues for work and action to better support caregivers and prevent work-related burnout
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None