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Clinical Trials/NCT04619901
NCT04619901
Recruiting
Not Applicable

How Parents (and Their Child if They Continue Their Life) Fare After a Decision of Palliative Care Has Been Taken in the Neonatal Period

University Hospital, Lille4 sites in 1 country34 target enrollmentStarted: February 12, 2020Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
University Hospital, Lille
Enrollment
34
Locations
4
Primary Endpoint
Semi Structured interview

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Semi Structured interview

Time Frame: 24 months after palliative care decision

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.

Secondary Outcomes

  • Intolerance to Uncertainty Scale (EEI)(24 months after palliative care decision)
  • Semi Structured Interview(24 months after palliative care decision)
  • Brief COPE(24 months after palliative care decision)
  • Ages and Stages Questionnaire (ASQ) - Clinical Examination of Child(24 months after palliative care decision)
  • Hospital Anxiety and Depression Scale (HADS)(24 months after palliative care decision)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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