Pilot of a perinatal palliative care program for parents facing severe fetal or early neonatal diagnoses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.