Palliative Care in Maternity and Neonatology

NCT ID: NCT04619901

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-12

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Palliative care is now an accepted principle in most maternity and neonatology wards, however not much is known about its psychological and social consequences on families. Some children continue their life after a palliative care decision has been taken. In France, quality of life and the neuro-developmental evolution of newborns who continue their life after a palliative care decision has been taken, have never been studied.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neonatal Critical Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Parents only

Semi-structured interviews

Intervention Type OTHER

Exploring the psychological and social impact on parents of a palliative care decision concerning their child in the neonatal period

Questionnaire

Intervention Type OTHER

Assessing the neuro-developmental evolution of children and understanding the determinants of the psychological and social impact of palliative care decisions on parents

following Scales

Intervention Type OTHER

Scales : Hospital Anxiety and Depression, Intolerance to Uncertainty, and Brief COPE.

Children and Parents

Questionnaire

Intervention Type OTHER

Assessing the neuro-developmental evolution of children and understanding the determinants of the psychological and social impact of palliative care decisions on parents

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Semi-structured interviews

Exploring the psychological and social impact on parents of a palliative care decision concerning their child in the neonatal period

Intervention Type OTHER

Questionnaire

Assessing the neuro-developmental evolution of children and understanding the determinants of the psychological and social impact of palliative care decisions on parents

Intervention Type OTHER

following Scales

Scales : Hospital Anxiety and Depression, Intolerance to Uncertainty, and Brief COPE.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Father and/or Mother of a child, who is alive or not, for whom a decision of palliative care has been made in the neonatal period
* Under the care of one of the Level 3 Maternity Centers in the North and Pas-de-Calais departments (Arras, Lens, Lille, Valenciennes) since 2018
* Written consent of the two legal guardians of the child allowing the collection of data concerning the child
* Written consent of the parent(s) participating to this study by completing the parental questionnaires

Exclusion Criteria

* Medico-legal complaint underway
* Parents who do not understand French
* Parents or children who are under legal protection (guardianship, curatorship)
* Parents or children who are not Social Security beneficiaries
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurent Storme, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CH ARRAS

Arras, , France

Site Status NOT_YET_RECRUITING

CH LENS

Lens, , France

Site Status NOT_YET_RECRUITING

Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status RECRUITING

CH Valenciennes

Valenciennes, , France

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laurent Storme, MD,PhD

Role: CONTACT

03 20 44 61 99 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Role: primary

0320445962

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A01226-49

Identifier Type: OTHER

Identifier Source: secondary_id

2017_14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.