Palliative Care in Maternity and Neonatology

Recruiting

• Conditions: Neonatal Critical Care
• Interventions: Other: Questionnaire; Other: Semi-structured interviews; Other: following Scales

• Registration Number: NCT04619901
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-12
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parents only	following Scales	-
Children and Parents	Questionnaire	-
Parents only	Semi-structured interviews	-
Parents only	Questionnaire	-

Primary Outcome Measures

Name	Time	Method
Semi Structured interview	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 Outcome Measures

Name	Time	Method
Intolerance to Uncertainty Scale (EEI)	24 months after palliative care decision	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.
Semi Structured Interview	24 months after palliative care decision	Parents : Determinants of the psychological and social impact of the palliative care decision
Brief COPE	24 months after palliative care decision	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
Ages and Stages Questionnaire (ASQ) - Clinical Examination of Child	24 months after palliative care decision	Child : Neuro-Developmental Assessment
Hospital Anxiety and Depression Scale (HADS)	24 months after palliative care decision	Parents :Psychometric Measure of Anxiety and Depression The scale allows to detect anxiety and depression using 14 items rated from 0-3.

Trial Locations

Locations (4)

CH Valenciennes; 🇫🇷 Valenciennes, France

CH ARRAS; 🇫🇷 Arras, France

CH LENS; 🇫🇷 Lens, France

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France