Palliative Care in Maternity and Neonatology (VESPAN)

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

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 Overview

• Status: Terminated
• Conditions: Neonatal Critical Care
• Intervention / Treatment: Other: Semi-structured interviews; Other: Questionnaire; Other: following Scales

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• France
  • Arras, France
    • CH Arras
  • Lens, France
    • CH LENS
  • Lille, France, 59037
    • Hop Jeanne de Flandre Chu Lille
  • Valenciennes, France
    • Ch Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parents only	Other: Semi-structured interviews; Exploring the psychological and social impact on parents of a palliative care decision concerning their child in the neonatal period; 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; Other: following Scales; Scales : Hospital Anxiety and Depression, Intolerance to Uncertainty, and Brief COPE.
Children and Parents	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Laurent Storme, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Palliative care; parents; newborn; Maternity
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 2017_14; 2018-A01226-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No