NCT04619901

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

October 14, 2020

Last Update Submit

January 25, 2023

Conditions

Neonatal Critical Care

Keywords

Palliative careMaternitynewbornparents

Outcome Measures

Primary Outcomes (1)

  • Semi Structured interview

    Parents : Exploring the psychological and social impact of the palliative care decision 2 hours semi structured interviews will be done to describe the psychological and social impact a decision of palliative care concerning their newborn infant has on parents.

    24 months after palliative care decision

Secondary Outcomes (5)

  • Ages and Stages Questionnaire (ASQ) - Clinical Examination of Child

    24 months after palliative care decision

  • Semi Structured Interview

    24 months after palliative care decision

  • Hospital Anxiety and Depression Scale (HADS)

    24 months after palliative care decision

  • Intolerance to Uncertainty Scale (EEI)

    24 months after palliative care decision

  • Brief COPE

    24 months after palliative care decision

Study Arms (2)

Parents only

Other: Semi-structured interviewsOther: QuestionnaireOther: following Scales

Children and Parents

Other: Questionnaire

Interventions

Semi-structured interviewsOTHER

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

Parents only
QuestionnaireOTHER

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

Children and ParentsParents only
following ScalesOTHER

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

Parents only

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

children and parents followed in pediatric unit whom a decision of palliative care has been made in the neonatal period

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CH ARRAS

Arras, France

NOT YET RECRUITING

CH LENS

Lens, France

NOT YET RECRUITING

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

RECRUITING

CH Valenciennes

Valenciennes, France

NOT YET RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Laurent Storme, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Storme, MD,PhD

CONTACT

03 20 44 61 99laurent.storme@chru-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2020

First Posted

November 6, 2020

Study Start

February 12, 2020

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

FR(4)