Pilot of a perinatal palliative care program for parents facing severe fetal or early neonatal diagnoses
Testing a Perinatal Palliative Care Intervention Program Within Standard Perinatal Healthcare: Pilot Testing Protocol
This pilot will test a perinatal palliative care program to support parents in Flanders who receive a severe fetal or early neonatal diagnosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vrije Universiteit Brussel Academic / other |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT06456034 on ClinicalTrials.gov |
What this trial studies
The program implements a coordinated perinatal palliative care pathway adapted to the Flemish context, offering clinical support to parents and training/support to healthcare providers. It enrolls parents who receive a severe fetal diagnosis after 20 weeks and either continue the pregnancy or undergo termination resulting in stillbirth, as well as parents of live-born infants with a severe neonatal diagnosis in the first week. Feasibility and preliminary effectiveness will be measured by comparing parental, clinical, and provider outcomes to baseline measurements collected on the same hospital wards before implementation. Outcome domains include parental wellbeing, decision-making support, bereavement outcomes, and provider acceptability and feasibility metrics.
Who should consider this trial
Good fit: Ideal candidates are parents over 18 who receive a severe fetal diagnosis after 20 weeks and decide to continue or terminate the pregnancy resulting in stillbirth, or parents of infants with a severe neonatal diagnosis within the first week, who speak Dutch or can participate with an interpreter and are deemed emotionally approachable by clinicians.
Not a fit: Patients under 18, those with a documented psychiatric disorder prior to the diagnosis, those judged not emotionally approachable by the treating team, or families outside the specified timeframe or geographic catchment are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the program could improve emotional support, decision support, and bereavement care for affected families while strengthening provider confidence in perinatal palliative practices.
How similar studies have performed: Perinatal palliative care programs have been described and associated with improved family satisfaction and bereavement support, but rigorous comparative trials are limited and context-specific implementation data remain scarce.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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" * 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).
Where this trial is running
Brussels and 1 other locations
- UZ Brussels — Brussels, Belgium (Recruiting)
- UZ Gent — Ghent, Belgium (Not_yet_recruiting)
Study contacts
- Principal investigator: Filip Cools — Brussels University Hospital
- Study coordinator: Laure Dombrecht
- Email: laure.dombrecht@vub.be
- Phone: +32476046563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.