Feeling of Caregivers After a Palliative Management of Extreme Premature Babies in Delivery Room.

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Caregiver Feeling
• Intervention / Treatment: Other: Assessment of caregiver feeling

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, 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).

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 caregiver's 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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • Recruiting
    • Chu Reims
    • Contact: Damien JOLLY, Pr.; Phone Number: 33 326788472; Email: djolly@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study group includes any caregiver who supported an extremely preterm newborn in a palliative care approach in the delivery room. Caregivers can be : senior pediatricians, senior obstetricians, midwifes, nurse's aides, pediatric nurses, pediatrician student, midwife student.

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of caregiver feeling	Semi-directional interviews will be carried out with the identification of the main themes during the verbatim transcription (qualitative study).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of stress	Revised Impact of Event Scale (IES-R) [Weiss, Brunet] scale	1 month
Assessment of stress	Revised Impact of Event Scale (IES-R) [Weiss, Brunet] scale	2 months

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Palliative care; Delivery room; Extremely preterm birth; Caregiver feeling
• Other Study ID Numbers: PO22027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No