Palliative Care in Maternity and Neonatology

Study Overview
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Brief Summary
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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.

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

Conditions
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Neonatal Critical Care

Intervention / Treatment
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* Other: Semi-structured interviews
* Other: Questionnaire
* Other: following Scales


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parents only<br> | Other: Semi-structured interviews<br>* Exploring the psychological and social impact on parents of a palliative care decision concerning their child in the neonatal period<br>Other: Questionnaire<br>* Assessing the neuro-developmental evolution of children and understanding the determinants of the psychological and social impact of palliative care decisions on parents<br>Other: following Scales<br>* Scales : Hospital Anxiety and Depression, Intolerance to Uncertainty, and Brief COPE.<br>|
| Children and Parents<br> | Other: Questionnaire<br>* Assessing the neuro-developmental evolution of children and understanding the determinants of the psychological and social impact of palliative care decisions on parents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ages and Stages Questionnaire (ASQ) - Clinical Examination of Child | Child : Neuro-Developmental Assessment | 24 months after palliative care decision | 
| Semi Structured Interview | Parents : Determinants of the psychological and social impact of the palliative care decision | 24 months after palliative care decision | 
| Hospital Anxiety and Depression Scale (HADS) | Parents :Psychometric Measure of Anxiety and Depression The scale allows to detect anxiety and depression using 14 items rated from 0-3. | 24 months after palliative care decision | 
| Intolerance to Uncertainty Scale (EEI) | Parents : Psychometric Measure of Intolerance to Uncertainty This questionnaire contains 27 items measuring emotions, cognitions and behaviours in ambiguous situations, the consequences of being uncertain and attempts to control the future.Items are rated on a Likert scale from 1 (Not at all matching) to 5 (Very matching). The total share is obtained by adding the items. | 24 months after palliative care decision | 
| Brief COPE | Parents : Psychometric Measure of Coping Strategies The Brief-COPE is a 28 item self-report questionnaire withs scoring and interpretation: Positive reframing / Planning/ Humor / Religion/Self-blame | 24 months after palliative care decision | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Maternity, newborn, parents