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Impact of Parental Presence at the Ethics Meeting in Neonatal Intensive Care (PaReNCo)

2 lipca 2026 zaktualizowane przez: Hôpital NOVO

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Parental Presence, Pediatric Ethics Consultation

Szczegółowy opis

End-of-life decisions account for a substantial proportion of deaths in neonatal intensive care units, exceeding 70% in some cohorts in Europe and North America. These decisions are most often made following a multidisciplinary collegial decision-making process.

In France, the legal framework (Loi Leonetti 2005, reinforced by Loi Claeys-Leonetti 2016) is based on the principles of non-obstination déraisonnable and proportionality of care. This framework does not require the formal presence of parents during collegial meetings.

International literature on shared decision-making is associated with improved parental outcomes. A French multicenter study (Caeymaex et al., 2013) reported that parental involvement in end-of-life decisions was associated with lower rates of complicated grief, including reduced feelings of guilt and exclusion.

Despite this, formal parental participation in collegial meetings remains uncommon in France, in the context of prevailing models of care and concerns regarding parental emotional burden.

Since 2018, the neonatal intensive care unit at Hôpital NOVO has offered parents the option to attend collegial meetings. This process includes prior preparation by the attending physician, who clarifies that final medical responsibility remains with the healthcare team, as well as optional psychological support before and/or after the meeting.

This model has been previously described (Boize et al., Arch Pédiatr, 2024), but parental subjective and emotional experiences have not been systematically evaluated. The PaReNCo study aims to assess these outcomes.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

100

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Veronique DA COSTA
Numer telefonu: 0033130755069
E-mail: veronique.dacosta@ght-novo.fr

Lokalizacje studiów

Francja
- - Cergy-Pontoise, Francja, 95300
    - Hopital Novo
    - Kontakt:
      
      Veronique DA COSTA
      
      Numer telefonu: 0033130755069
      
      E-mail: veronique.dacosta@ght-novo.fr

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria:

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

Exclusion Criteria:

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Parents' understanding of the medical decision made for their child following the ethics meeting. Ramy czasowe: Questionnaire completion (15 minutes per parent)	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).	Questionnaire completion (15 minutes per parent)

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Overall emotional experience of the ethics meeting Ramy czasowe: Questionnaire completion (15 minutes per parent)	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).	Questionnaire completion (15 minutes per parent)
Parental attendance rate at the ethics meeting Ramy czasowe: Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/2025	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.	Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/2025
Mortality rate of newborns for whom an ethics meeting was organized. Ramy czasowe: Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/2025	Number of deceased newborns divided by the number of newborns for whom an ethics meeting was organized, collected from the medical record	Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/2025
Parental feeling of guilt regarding the decision Ramy czasowe: Questionnaire completion (15 minutes per parent)	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).	Questionnaire completion (15 minutes per parent)
Parental acceptance of the decision made by the medical team. Ramy czasowe: Questionnaire completion (15 minutes per parent)	Assessed using questionnaire items 8, 11, 18, 19, 22, 23, 24, 25 and 26 (parents present) and items 11 and 16 (parents not present).	Questionnaire completion (15 minutes per parent)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hôpital NOVO

Śledczy

Główny śledczy: Suzanne BORRHOMEE, Dr, Hôpital NOVO - Site Pontoise

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 listopada 2026

Ukończenie studiów (Szacowany)

1 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

26 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości