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

June 13, 2024 updated by: CHU de Reims

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • Recruiting
        • Chu Reims
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of caregiver feeling
Time Frame: 1 month
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of stress
Time Frame: 1 month
Revised Impact of Event Scale (IES-R) [Weiss, Brunet] scale
1 month
Assessment of stress
Time Frame: 2 months
Revised Impact of Event Scale (IES-R) [Weiss, Brunet] scale
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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