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

2 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parents' understanding of the medical decision made for their child following the ethics meeting.
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall emotional experience of the ethics meeting
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hôpital NOVO

Onderzoekers

  • Hoofdonderzoeker: Suzanne BORRHOMEE, Dr, Hôpital NOVO - Site Pontoise

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 november 2026

Studieregistratiedata

Eerst ingediend

26 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

2 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • CHRD0624
  • 2026-A00780-51 (Andere identificatie: ANSM)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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