Parental Presence, Pediatric Ethics ConsultationPaReNCoNCT07681518
Impact of Parental Presence at the Ethics Meeting in Neonatal Intensive Care
An observational study of Parental Presence, Pediatric Ethics Consultation, run by Hôpital NOVO at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parental Presence, Pediatric Ethics Consultation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital NOVO
Cergy-Pontoise, 95300
Veronique DA COSTA, 0033130755069, veronique.dacosta@ght-novo.fr
About this study
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.
Read more
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.
Read the detailed description
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.
- Keywords
- Neonatal intensive care, End-of-life decision-making, Ethics consultation, Collegial meeting, Parental experience
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Questionnaire completion (15 minutes per parent)
Secondary outcomes (5)
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).
Measured: Questionnaire completion (15 minutes per parent)
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.
Measured: 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.
Number of deceased newborns divided by the number of newborns for whom an ethics meeting was organized, collected from the medical record
Measured: Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/2025
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).
Measured: Questionnaire completion (15 minutes per parent)
Parental acceptance of the decision made by the medical team.
Assessed using questionnaire items 8, 11, 18, 19, 22, 23, 24, 25 and 26 (parents present) and items 11 and 16 (parents not present).
Measured: Questionnaire completion (15 minutes per parent)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parental Presence, Pediatric Ethics ConsultationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne BORRHOMEE, Dr, Principal investigator, Hôpital NOVO - Site Pontoise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681518
- Sponsor's protocol ID
- CHRD0624
- Other IDs
- 2026-A00780-51
- Acronym
- PaReNCo
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Parental Presence at the Ethics Meeting in Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT07681518
- Acronym / sponsor ID
- PaReNCo / CHRD0624
- Keywords
- Neonatal intensive care, End-of-life decision-making, Ethics consultation, Collegial meeting, Parental experience
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parents' understanding of the medical decision made for their child following the ethics meeting.
Time frame: 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).
5 secondary outcomes
Overall emotional experience of the ethics meeting
Time frame: Questionnaire completion (15 minutes per parent)
Parental attendance rate at the ethics meeting
Time frame: 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.
Time frame: Retrospective assessment for ethics meetings organized between 01/01/2018 and 31/12/2025
Parental feeling of guilt regarding the decision
Time frame: Questionnaire completion (15 minutes per parent)
Parental acceptance of the decision made by the medical team.
Time frame: Questionnaire completion (15 minutes per parent)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne BORRHOMEE, Dr principal investigator
Hôpital NOVO - Site Pontoise
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parental Presence, Pediatric Ethics Consultation, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Véronique DA COSTA (0033130755069, veronique.dacosta@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' understanding of the medical decision made for their child following the ethics meeting. (time frame: Questionnaire completion (15 minutes per parent)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.