Neonatal Critical CareVESPANNCT04619901
Palliative Care in Maternity and Neonatology
An observational study of Neonatal Critical Care, run by University Hospital, Lille at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Critical Care
- What is being tested?
- Semi-structured interviews, Questionnaire and following Scales
- How many people
- 1 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Feb 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children and parents followed in pediatric unit whom a decision of palliative care has been made in the neonatal period
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH ARRAS
Arras
CH LENS
Lens
Hop Jeanne de Flandre Chu Lille
Lille, 59037
CH Valenciennes
Valenciennes
About this study
Official title: 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.
- Conditions
- Neonatal Critical Care
- Being tested
- Semi-structured interviews, Questionnaire, following Scales
- Keywords
- Palliative care, Maternity, newborn, parents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
Exploring the psychological and social impact on parents of a palliative care decision concerning their child in the neonatal period
QuestionnaireOther
Assessing the neuro-developmental evolution of children and understanding the determinants of the psychological and social impact of palliative care decisions on parents
following ScalesOther
Scales : Hospital Anxiety and Depression, Intolerance to Uncertainty, and Brief COPE.
| Study group | Role | What they receive |
|---|---|---|
| Parents only | Not described Receives: Other: Semi-structured interviews; Other: Questionnaire; Other: following Scales | |
| Children and Parents | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after palliative care decision
Secondary outcomes (5)
Ages and Stages Questionnaire (ASQ) - Clinical Examination of Child
Child : Neuro-Developmental Assessment
Measured: 24 months after palliative care decision
Semi Structured Interview
Parents : Determinants of the psychological and social impact of the palliative care decision
Measured: 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.
Measured: 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.
Measured: 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
Measured: 24 months after palliative care decision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start12 Feb 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Critical CareStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Storme, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619901
- Sponsor's protocol ID
- 2017_14
- Other IDs
- 2018-A01226-49
- Acronym
- VESPAN
- Status last verified
- May 2026
- First submitted
- 14 Oct 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Parents (and Their Child if They Continue Their Life) Fare After a Decision of Palliative Care Has Been Taken in the Neonatal Period
- ClinicalTrials.gov ID
- NCT04619901
- Acronym / sponsor ID
- VESPAN / 2017_14
- Conditions
- Neonatal Critical Care
- Keywords
- Palliative care, Maternity, newborn, parents
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents only | – | Other: Semi-structured interviews, Other: Questionnaire, Other: following Scales |
| Children and Parents | – | Other: Questionnaire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children and parents followed in pediatric unit whom a decision of palliative care has been made in the neonatal period
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewsExploring the psychological and social impact on parents of a palliative care decision concerning their child in the neonatal period | Other | Parents only |
| QuestionnaireAssessing the neuro-developmental evolution of children and understanding the determinants of the psychological and social impact of palliative care decisions on parents | Other | Children and Parents, Parents only |
| following ScalesScales : Hospital Anxiety and Depression, Intolerance to Uncertainty, and Brief COPE. | Other | Parents only |
Primary outcome
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.
5 secondary outcomes
Ages and Stages Questionnaire (ASQ) - Clinical Examination of Child
Time frame: 24 months after palliative care decision
Semi Structured Interview
Time frame: 24 months after palliative care decision
Hospital Anxiety and Depression Scale (HADS)
Time frame: 24 months after palliative care decision
Intolerance to Uncertainty Scale (EEI)
Time frame: 24 months after palliative care decision
Brief COPE
Time frame: 24 months after palliative care decision
Results and safety
The study was stopped early (reason given: COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Storme, MD,PhD principal investigator
University Hospital, Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Critical Care, run by University Hospital, Lille at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi Structured interview (time frame: 24 months after palliative care decision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.