Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

2 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Parental Presence, Pediatric Ethics Consultation

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Veronique DA COSTA
Numero di telefono: 0033130755069
Email: veronique.dacosta@ght-novo.fr

Luoghi di studio

Francia
- - Cergy-Pontoise, Francia, 95300
    - Hopital Novo
    - Contatto:
      
      Veronique DA COSTA
      
      Numero di telefono: 0033130755069
      
      Email: veronique.dacosta@ght-novo.fr

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Parents' understanding of the medical decision made for their child following the ethics meeting. Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Overall emotional experience of the ethics meeting Lasso di tempo: 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 Lasso di tempo: 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. Lasso di tempo: 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 Lasso di tempo: 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. Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hôpital NOVO

Investigatori

Investigatore principale: Suzanne BORRHOMEE, Dr, Hôpital NOVO - Site Pontoise

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 novembre 2026

Date di iscrizione allo studio

Primo inviato

26 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità