Caregiver FeelingNCT06458114
Feeling of Caregivers After a Palliative Management of Extreme Premature Babies in Delivery Room.
An observational study of Caregiver Feeling, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Feeling
- What is being tested?
- Assessment of caregiver feeling
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2022to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, Pr., 326788472 ext. 33, djolly@chu-reims.fr
About this study
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.
Introduction :
The birth of a child is usually a happy event that caregivers working in delivery rooms share with families.
Read more
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.
Read the 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.
- Conditions
- Caregiver Feeling
- Being tested
- Assessment of caregiver feeling
- Keywords
- Caregiver feeling, Palliative care, Delivery room, Extremely preterm birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of caregiver feelingOther
The study group includes any caregiver who supported an extremely preterm newborn in a palliative care approach in the delivery room with as intervention type a questionnaire and individual semi-structured interview.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of caregiver feeling
Semi-directional interviews will be carried out with the identification of the main themes during the verbatim transcription (qualitative study).
Measured: 1 month
Secondary outcomes (2)
Assessment of stress
Revised Impact of Event Scale (IES-R) [Weiss, Brunet] scale
Measured: 1 month
Assessment of stress
Revised Impact of Event Scale (IES-R) [Weiss, Brunet] scale
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start7 May 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver FeelingStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458114
- Sponsor's protocol ID
- PO22027
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06458114
- Acronym / sponsor ID
- PO22027
- Conditions
- Caregiver Feeling
- Keywords
- Caregiver feeling, Palliative care, Delivery room, Extremely preterm birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 7 May 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of caregiver feelingThe study group includes any caregiver who supported an extremely preterm newborn in a palliative care approach in the delivery room with as intervention type a questionnaire and individual semi-structured interview. | Other | – |
Primary outcome
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).
2 secondary outcomes
Assessment of stress
Time frame: 1 month
Assessment of stress
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver Feeling, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of caregiver feeling (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.