Perinatal Palliative CarePPC-pilotNCT06456034
Pilot-testing a Perinatal Palliative Care Intervention Program
A study testing Perinatal palliative care in people with Perinatal Palliative Care and Life-limiting Fetal Diagnosis, run by Vrije Universiteit Brussel at 2 sites in Belgium.
Trial summary
The objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the Flemish context, which aims to provide care to parents who receive a severe foetal/neonatal diagnosis for their (unborn) child and to their healthcare providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perinatal Palliative Care, Life-limiting Fetal Diagnosis, Life-limiting Neonatal Diagnosis
- What is being tested?
- Perinatal palliative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesBelgium
- Study dates
- 18 May 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents:
- who receive a severe foetal diagnosis for their unborn child and decide to continue the pregnancy after 20 weeks of gestation , or
- who receive a severe foetal diagnosis for their unborn child after 20 weeks gestation and decide to terminate the pregnancy (with or without feticide) resulting in the stillbirth of their child
- Parents who receive a severe neonatal diagnosis for their live-born infant in the first week after birth
- Additional inclusion criteria for parents:
- Parents are either Dutch speaking, or are willing to participate with support from a (phone or real life) interpreter, in collaboration with the "Agentschap Integratie \& Inburgering"
Show all 10Show fewer
- Parents are older than 18
- Parents are not suffering from an officially diagnosed psychiatric disorder prior to receiving the severe diagnosis of their child
- Parents are deemed (emotionally) approachable for the current study by the treating physician
- For each family included in the pilot study, the physicians and nurses/midwives who will be/are most closely involved in the care of the infant and the parents will also be asked to participate. If healthcare providers refuse to provide informed consent to participate in the study, their data will be deemed as missing for that case (parental outcomes are considered as the primary outcome measures).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
UZ Brussels
Brussels, 1090
Laure Dombrecht, 0476046563, laure.dombrecht@vub.be
- Not yet recruiting
UZ Gent
Ghent, 9000
Laure Dombrecht, 0476046563, laure.dombrecht@ugent.be
About this study
Official title: Testing a Perinatal Palliative Care Intervention Program Within Standard Perinatal Healthcare: Pilot Testing Protocol
The objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the Flemish context, which aims to provide care to parents who receive a severe foetal/neonatal diagnosis for their (unborn) child and to their healthcare providers. Additionally, we aim to evaluate the feasibility and preliminary effectiveness by comparing measured variables to the baseline measurement done in the same hospital wards beforehand.
- Conditions
- Perinatal Palliative Care, Life-limiting Fetal Diagnosis, Life-limiting Neonatal Diagnosis
- Being tested
- Perinatal palliative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perinatal palliative careBehavioural
Intervention group will receive specialized perinatal palliative care support from moment of severe perinatal diagnosis. This intervention is aimed at 5 major care components, namely 1. Support offered by a fixed perinatal palliative care team, 2. that team has received specialized perinatal palliative care training, 3. care is structured within a new perinatal palliative care approach or pathway, including fixed means of communication with team members, 4. psychological support is structurally being offered to parents and healthcare providers, and 5. debriefings after every perinatal death are being organized in the involved team.
| Study group | Role | What they receive |
|---|---|---|
| Baseline group | No intervention | Receives care as usual after severe perinatal diagnosis |
| Perinatal palliative care group | Experimental | Receives a new perinatal palliative care intervention after severe perinatal diagnosis Receives: Behavioral: Perinatal palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
NeoComfort scale
The validated NeoComfort scale will be used to assess pain and discomfort. The COMFORTneo scale is composed of 7 behavioral dimensions: As respiratory response applies to ventilated neonates only, and crying to spontaneously breathing neonates only (including those requiring continuous positive airway pressure), the rater will actually rate 6 dimensions. Alertness, calmness/agitation, facial tension, muscle tone, body movement are rated for all neonates. As responses are on a 1 to 5 Likert scale, total scores range from 6 to 30-with higher scores indicating more pain.scores range from 6 to 30-with higher scores indicating more pain.
Measured: every four hours (six times per day) during care provision for neonates only
Administered medication and procedures
All medication administration and procedures followed are registered throughout the care trajectory. Duration or timing is impossible to predict.
Measured: during care provision
Contact moments with healthcare providers
Contact moments between healthcare providers and parents are registered throughout the care trajectory. Duration or timing is impossible to predict.
Measured: during care provision
Parental Perinatal Grief Scale
Scoring of the parental Perinatal Grief Scale. The short version of the Perinatal Grief Scale consists of 33 items that represents three subscales each consisting of 11 items: active grief (sadness, missing the baby, crying for the baby), difficulty coping (difficulty in dealing with normal activities with other people, withdrawal and depression), and despair (feelings of worthlessness and hopelessness). Each item is scored on a 5-point likert scale, resulting in a possible range of 33-165. Higher scores reflect more intense grief.
Measured: 2 weeks after final contact moment or 6 months post inclusion
Parental Brief-COPE
Scoring of parental Brief-COPE (Coping Orientation to Problems Experienced Inventory) questionnaire. The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. "Coping" is defined broadly as an effort used to minimize distress associated with negative life experiences. The scale can determine someone's primary coping styles with scores on the following three subscale: Problem-Focused Coping; Emotion-Focused Coping; and Avoidant Coping. Scores are presented for the three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style (higher scores = more engagement of that coping style).
Measured: 2 weeks after final contact moment or 6 months post inclusion
Parental Satisfaction of Perinatal Palliative Care
Scoring of The Parental Satisfaction of Perinatal Palliative Care Instrument, which was developed to identify and measure parental satisfaction in perinatal palliative care for parents who opt to continue a pregnancy with a life-limiting fetal diagnosis. The instrument measures parent-reported care delivery addressing the pregnancy time continuum in three scales (Prenatal; Intrapartum; Postnatal). Items in the instrument are on a Likert scale from 1-7, with 1 indicating "strongly disagree," 4 indicating "does not apply/neutral," and 7 indicating "strongly agree." Higher scores reflect higher parental perception of quality care delivery. The Prenatal Scale includes 37 items (range from 37-259); the Intrapartum Scale includes 37 items (range from 37-259); and the Postnatal Scale includes 44 items (range from 44-308).
Measured: 2 weeks after final contact moment or 6 months post inclusion
Healthcare provider Compassion Satisfaction and Fatigue questionnaire
Scoring of Healthcare provider Compassion Satisfaction and Fatigue questionnaire. ProQOL is a survey consisting of 30 items scaled on a five-point Likert scale, measuring three subscales consisting of 10 items each: Compassion Satisfaction, Burnout and Secondary Traumatic Stress. The Compassion satisfaction scale is about the pleasure derived from your work, with higher scores indicating that you derive a good deal of professional satisfaction from your position (range of 10-50). The burnout subscale is associated with feelings of hopelessness and difficulties in dealing with work or in doing your job effectively. Higher scores on this scale mean that you are at higher risk for burnout (range of 10-50). The secondary traumatic stress scale is about your work-related, secondary exposure to extremely or traumatically stressful events, with a higher score indicating a higher amount of experienced secondary traumatic stress (range of 10-50).
Measured: 2 weeks after final contact moment or 6 months post inclusion
Healthcare provider Professional Satisfaction with Provided Care
Scoring of Healthcare provider Professional Satisfaction with Provided Care. This is a self-developed (not yet validated) questionnaire on Professional Satisfaction with Provided Care consisting of 48 items, based on the existing Parental Satisfaction of Perinatal Palliative Care Instrument used in the parental assessment, to assess whether healthcare providers are satisfied with the perinatal palliative care they and their team provided in a particular case, including satisfaction with communication among the team, and communication with parents. Psychometric properties of the scale need to be determined after the pilot test.
Measured: 2 weeks after final contact moment or 6 months post inclusion
Healthcare provider experienced (psychological) support
Scoring of Healthcare provider experienced (psychological) support. This is a short, self-developed (not yet validated) questionnaire consisting of 6 items for physicians or 6 items for nurses, to assess the amound of (psychological) support that healthcare providers received during the care provision for this particular case. Psychometric properties of the scale need to be determined after the pilot test.
Measured: 2 weeks after final contact moment or 6 months post inclusion
Secondary outcomes (2)
Parental feasibility and acceptability of pilot
Parental feasibility and acceptability of pilot. As assessed by means of interviews.
Measured: 2 weeks after final contact moment or 6 months post inclusion
Healthcare provider feasibility and acceptability of pilot
Healthcare provider feasibility and acceptability of pilot. As assessed by means of interviews.
Measured: 2 weeks after final contact moment or 6 months post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start18 May 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Palliative CareStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laure Dombrecht, Vrije Universiteit Brussel
- Investigators
- Filip Cools, Principal investigator, Brussels University HospitalKristien Roelens, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456034
- Sponsor's protocol ID
- PPC-pilot
- Acronym
- PPC-pilot
- Status last verified
- Sep 2025
- First submitted
- 6 Jun 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Perinatal Palliative Care Intervention Program Within Standard Perinatal Healthcare: Pilot Testing Protocol
- ClinicalTrials.gov ID
- NCT06456034
- Acronym / sponsor ID
- PPC-pilot / PPC-pilot
- Conditions
- Perinatal Palliative Care, Life-limiting Fetal Diagnosis, Life-limiting Neonatal Diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 18 May 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Jun 2024 (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.
The objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the Flemish context, which aims to provide care to parents who receive a severe foetal/neonatal diagnosis for their (unborn) child and to their healthcare providers. Additionally, we aim to evaluate the feasibility and preliminary effectiveness by comparing measured variables to the baseline measurement done in the same hospital wards beforehand.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline group | No intervention | –Receives care as usual after severe perinatal diagnosis |
| Perinatal palliative care group | Experimental | Behavioral: Perinatal palliative careReceives a new perinatal palliative care intervention after severe perinatal diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Parents:
- Parents who receive a severe neonatal diagnosis for their live-born infant in the first week after birth
- Parents are either Dutch speaking, or are willing to participate with support from a (phone or real life) interpreter, in collaboration with the "Agentschap Integratie \& Inburgering"
- Parents are older than 18
- Parents are not suffering from an officially diagnosed psychiatric disorder prior to receiving the severe diagnosis of their child
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Perinatal palliative careIntervention group will receive specialized perinatal palliative care support from moment of severe perinatal diagnosis. This intervention is aimed at 5 major care components, namely 1. Support offered by a fixed perinatal palliative care team, 2. that team has received specialized perinatal palliative care training, 3. care is structured within a new perinatal palliative care approach or pathway, including fixed means of communication with team members, 4. psychological support is structurally being offered to parents and healthcare providers, and 5. debriefings after every perinatal death are being organized in the involved team. | Behavioural | Perinatal palliative care group |
Primary outcome
NeoComfort scale
Time frame: every four hours (six times per day) during care provision for neonates only
The validated NeoComfort scale will be used to assess pain and discomfort. The COMFORTneo scale is composed of 7 behavioral dimensions: As respiratory response applies to ventilated neonates only, and crying to spontaneously breathing neonates only (including those requiring continuous positive airway pressure), the rater will actually rate 6 dimensions. Alertness, calmness/agitation, facial tension, muscle tone, body movement are rated for all neonates. As responses are on a 1 to 5 Likert scale, total scores range from 6 to 30-with higher scores indicating more pain.scores range from 6 to 30-with higher scores indicating more pain.
Administered medication and procedures
Time frame: during care provision
All medication administration and procedures followed are registered throughout the care trajectory. Duration or timing is impossible to predict.
Contact moments with healthcare providers
Time frame: during care provision
Contact moments between healthcare providers and parents are registered throughout the care trajectory. Duration or timing is impossible to predict.
Parental Perinatal Grief Scale
Time frame: 2 weeks after final contact moment or 6 months post inclusion
Scoring of the parental Perinatal Grief Scale. The short version of the Perinatal Grief Scale consists of 33 items that represents three subscales each consisting of 11 items: active grief (sadness, missing the baby, crying for the baby), difficulty coping (difficulty in dealing with normal activities with other people, withdrawal and depression), and despair (feelings of worthlessness and hopelessness). Each item is scored on a 5-point likert scale, resulting in a possible range of 33-165. Higher scores reflect more intense grief.
Parental Brief-COPE
Time frame: 2 weeks after final contact moment or 6 months post inclusion
Scoring of parental Brief-COPE (Coping Orientation to Problems Experienced Inventory) questionnaire. The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. "Coping" is defined broadly as an effort used to minimize distress associated with negative life experiences. The scale can determine someone's primary coping styles with scores on the following three subscale: Problem-Focused Coping; Emotion-Focused Coping; and Avoidant Coping. Scores are presented for the three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style (higher scores = more engagement of that coping style).
Parental Satisfaction of Perinatal Palliative Care
Time frame: 2 weeks after final contact moment or 6 months post inclusion
Scoring of The Parental Satisfaction of Perinatal Palliative Care Instrument, which was developed to identify and measure parental satisfaction in perinatal palliative care for parents who opt to continue a pregnancy with a life-limiting fetal diagnosis. The instrument measures parent-reported care delivery addressing the pregnancy time continuum in three scales (Prenatal; Intrapartum; Postnatal). Items in the instrument are on a Likert scale from 1-7, with 1 indicating "strongly disagree," 4 indicating "does not apply/neutral," and 7 indicating "strongly agree." Higher scores reflect higher parental perception of quality care delivery. The Prenatal Scale includes 37 items (range from 37-259); the Intrapartum Scale includes 37 items (range from 37-259); and the Postnatal Scale includes 44 items (range from 44-308).
Healthcare provider Compassion Satisfaction and Fatigue questionnaire
Time frame: 2 weeks after final contact moment or 6 months post inclusion
Scoring of Healthcare provider Compassion Satisfaction and Fatigue questionnaire. ProQOL is a survey consisting of 30 items scaled on a five-point Likert scale, measuring three subscales consisting of 10 items each: Compassion Satisfaction, Burnout and Secondary Traumatic Stress. The Compassion satisfaction scale is about the pleasure derived from your work, with higher scores indicating that you derive a good deal of professional satisfaction from your position (range of 10-50). The burnout subscale is associated with feelings of hopelessness and difficulties in dealing with work or in doing your job effectively. Higher scores on this scale mean that you are at higher risk for burnout (range of 10-50). The secondary traumatic stress scale is about your work-related, secondary exposure to extremely or traumatically stressful events, with a higher score indicating a higher amount of experienced secondary traumatic stress (range of 10-50).
Healthcare provider Professional Satisfaction with Provided Care
Time frame: 2 weeks after final contact moment or 6 months post inclusion
Scoring of Healthcare provider Professional Satisfaction with Provided Care. This is a self-developed (not yet validated) questionnaire on Professional Satisfaction with Provided Care consisting of 48 items, based on the existing Parental Satisfaction of Perinatal Palliative Care Instrument used in the parental assessment, to assess whether healthcare providers are satisfied with the perinatal palliative care they and their team provided in a particular case, including satisfaction with communication among the team, and communication with parents. Psychometric properties of the scale need to be determined after the pilot test.
Healthcare provider experienced (psychological) support
Time frame: 2 weeks after final contact moment or 6 months post inclusion
Scoring of Healthcare provider experienced (psychological) support. This is a short, self-developed (not yet validated) questionnaire consisting of 6 items for physicians or 6 items for nurses, to assess the amound of (psychological) support that healthcare providers received during the care provision for this particular case. Psychometric properties of the scale need to be determined after the pilot test.
2 secondary outcomes
Parental feasibility and acceptability of pilot
Time frame: 2 weeks after final contact moment or 6 months post inclusion
Healthcare provider feasibility and acceptability of pilot
Time frame: 2 weeks after final contact moment or 6 months post inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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.
Filip Cools principal investigator
Brussels University Hospital
Kristien Roelens principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perinatal palliative care in people with Perinatal Palliative Care and Life-limiting Fetal Diagnosis, run by Vrije Universiteit Brussel at 2 sites in Belgium.
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 10 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laure Dombrecht (+32476046563, laure.dombrecht@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NeoComfort scale (time frame: every four hours (six times per day) during care provision for neonates only). The study lists 9 primary outcomes in all. 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 Sep 2025.