NCT06456034 Pilot-testing a Perinatal Palliative Care Intervention Program
| NCT ID | NCT06456034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vrije Universiteit Brussel |
| Condition | Perinatal Palliative Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-18 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-05-18 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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).
Contact & Investigator
Filip Cools
PRINCIPAL INVESTIGATOR
Brussels University Hospital
Frequently Asked Questions
Who can join the NCT06456034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Perinatal Palliative Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06456034 currently recruiting?
Yes, NCT06456034 is actively recruiting participants. Contact the research team at laure.dombrecht@vub.be for enrollment information.
Where is the NCT06456034 trial being conducted?
This trial is being conducted at Brussels, Belgium, Ghent, Belgium.
Who is sponsoring the NCT06456034 clinical trial?
NCT06456034 is sponsored by Vrije Universiteit Brussel. The principal investigator is Filip Cools at Brussels University Hospital. The trial plans to enroll 20 participants.