Impact of Parental Presence at the Ethics Meeting in Neonatal Intensive Care
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital NOVO
About this trial
In neonatal intensive care, physicians are sometimes confronted with decisions to withhold or withdraw life-sustaining treatment for a critically ill newborn. In France, these decisions are made by the medical team through a formal collegial ("ethics") meeting. Parents are not legally required to take part in this meeting, and their participation remains very rare at the national level.
Since 2018, the neonatal intensive care unit of Hopital NOVO (Nord Ouest Val d'Oise) (Pontoise site) has systematically offered parents the possibility of attending the collegial ethics meeting concerning their child when withholding or withdrawal of treatment is being considered. This study aims to evaluate the value of parental presence at the ethics meeting in helping parents understand the medical decisions made for their newborn.
This is a retrospective, single-centre, non-interventional, qualitative study based on a questionnaire developed specifically for this purpose, in the absence of any validated tool. Parents of newborns for whom an ethics meeting was held between 1 January 2018 and 31 December 2025 are invited to share their experience. Two questionnaire versions are used, one for parents who attended the meeting and one for parents who did not, allowing comparison between the two situations. The questionnaire explores parents' understanding of the decision, the emotional impact of the meeting, their sense of guilt and their acceptance of the decision.
Main hypothesis: parental participation in the ethics meeting promotes a better understanding of the medical decision, reduces feelings of guilt, and improves parents' long-term emotional experience.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult parent (≥18 years)
Parent of a newborn for whom an ethics meeting was organized within the neonatal intensive care unit of Hôpital NOVO - Pontoise site
Ethics meeting organized between 01/01/2018 and 31/12/2025
Disqualifiers
Refusal to participate in the study (refusal to complete the questionnaire and refusal to allow use of the child's medical record data)
Parent with a major inability to understand the study (severe cognitive impairment)
Parent not understanding French and therefore unable to complete the questionnaire
Trial population
Parents of newborns for whom a collegial ethics meeting was organized between 1 January 2018 and 31 December 2025, in the neonatal intensive care unit of Hôpital Novo (Pontoise site, France). Families are identified retrospectively from the unit's internal record of ethics meetings held during this period; parents are then contacted prospectively to take part in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Parents' understanding of the medical decision made for their child following the ethics meeting.
Self-reported understanding assessed with the study-specific questionnaire (items 14, 15, 16 and 17 for parents who attended the meeting; items 6, 7, 10 and 14 for parents who did not attend), with responses rated on a 1-5 Likert scale (1 = not all, 5 = completely).
Time frame
Questionnaire completion (15 minutes per parent)Secondary outcomes
1
Overall emotional experience of the ethics meeting
Overall emotional experience concerning the meeting, assessed using a study-specific questionnaire (questions 4, 5, 6, 7, 9, 12, 13 and 21 for parents who attended the meeting; questions 4, 5, 9, 13, 15 and 17 for parents who did not attend).
Time frame
Questionnaire completion (15 minutes per parent)2
Parental attendance rate at the ethics meeting
Parental attendance rate at the ethics meeting, defined as the number of parents who attended the meeting divided by the number of parents invited to attend the meeting concerning their child.
Time frame
Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/20253
Mortality rate of newborns for whom an ethics meeting was organized.
Number of deceased newborns divided by the number of newborns for whom an ethics meeting was organized, collected from the medical record
Time frame
Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/20254
Parental feeling of guilt regarding the decision
Parents' feeling of guilt at the time of the ethics meeting (questions 10 and 20 for parents present; questions 8 and 12 for parents not present).
Time frame
Questionnaire completion (15 minutes per parent)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: