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

2 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Parents' understanding of the medical decision made for their child following the ethics meeting.
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall emotional experience of the ethics meeting
Délai: 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
Délai: 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.
Délai: 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
Délai: 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.
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hôpital NOVO

Les enquêteurs

  • Chercheur principal: Suzanne BORRHOMEE, Dr, Hôpital NOVO - Site Pontoise

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 novembre 2026

Achèvement de l'étude (Estimé)

1 novembre 2026

Dates d'inscription aux études

Première soumission

26 juin 2026

Première soumission répondant aux critères de contrôle qualité

26 juin 2026

Première publication (Réel)

2 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • CHRD0624
  • 2026-A00780-51 (Autre identifiant: ANSM)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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