Neonatal DeathEvDPMNNNCT03368248
Evaluation of the Palliative Approach in the NICU
An observational study of Neonatal Death, run by Hôpital NOVO at 1 site in France.
Trial summary
In neonatal resuscitation, the majority of deaths currently occur after a Life Limitation or Discontinuance (LAT) procedure. In the 1990s, the approach was different, as Marina CUTTINI put it in a European study that highlighted some French peculiarities: doctors and nurses found it legitimate to have life stops in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neonatal Death
- What is being tested?
- Survey
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 1 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Medico-caring staff of the NICUs in the Paris region.
Who may be able to join
- medico-caring staff of the NICUs in the Paris region
Who cannot join
- No response to the supplementary questionnaire, not allowing to assess the response rate of the center
Trial locations and contacts
1 site in 1 country.
About this study
In neonatal resuscitation, the majority of deaths currently occur after a Life Limitation or Discontinuance (LAT) procedure. In the 1990s, the approach was different, as Marina CUTTINI put it in a European study that highlighted some French peculiarities: doctors and nurses found it legitimate to have life stops in certain circumstances, and wanted to keep parents away from these decisions deemed guilt. Civil society has changed the thinking in recent years by the so-called Kouchner then LEONETTI laws. The palliative approach, which is defined as the search for a fair and reasonable balance, constantly reevaluated, between curative care and care of comfort and support, has become a constant concern in neonatal resuscitation services. However, we did not find a recent study that specifies in France the modalities of deaths in neonatology, especially their proportion after LAT. Also, shortly before the adoption of the CLAYES-LEONETTI law, the authors wished to make an inventory of the practices of all the neonatal intensive care units of Ile de France, one of the main centers of French fertility.
The objectives of the study were to describe the organization of collegial meetings (CR), the decision-making process and implementation of LATs, with particular attention to stopping artificial nutrition and hydration, and sedation / analgesia. The place of the parents in these different processes (gathering their opinion, information on how to withdraw life-saving treatment, leading in the event of disagreement) was also studied. Finally, some questions about euthanasia were asked, in order to measure the evolution of ideas and practices more than 15 years after EURONIC and 10 years after the LEONETTI law.
Read the detailed description
This is a survey carried out among all neonatal resuscitation services in the Ile-de-France region, from January 1 to 31, 2016. All professionals in contact with children were interviewed: doctors (senior and intern), paramedics (managers, pediatric nurses, auxiliaries and nurses, psychomotor therapists) and psychologists. The survey was based on a questionnaire, which was offered to all professionals, both medical and non-medical. All questions were closed, and a free comment area was proposed at the end. The questionnaire was preceded by a comment recalling the objectives of the study, the voluntary and individual nature of participation, and insisted on respect for anonymity. It consisted of 49 questions, allowing 197 possible answers. For most questions, several answers could be chosen. An additional questionnaire was sent to the heads of the services, medical and care settings. The questions sought to describe the 2014 activity (number of admissions and number of deaths, number of collegiate meetings and number of deaths resulting from an LAT), medical and paramedical staff to calculate the response rate, the existence of reflection and / or training on palliative and end-of-life care in the service, as well as the existence of a mobile team or palliative care unit in the facility.
- Conditions
- Neonatal Death
- Being tested
- Survey
- Keywords
- Palliative care, Collegial meetings, Neonatal resuscitation services, Survey, Medico-caring staff of the NICUs
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
A survey was conducted among all professionals in neonatal resuscitation services : doctors (senior and intern), paramedics (managers, pediatric nurses, auxiliaries and nurses, psychomotor therapists) and psychologists. The survey was based on a questionnaire, which was offered to all professionals, both medical and non-medical. All questions were closed, and a free comment area was proposed at the end. The questionnaire was preceded by a comment recalling the objectives of the study, the voluntary and individual nature of participation, and insisted on respect for anonymity. It consisted of 49 questions, allowing 197 possible answers. For most questions, several answers could be chosen.
| Study group | Role | What they receive |
|---|---|---|
| All neonatal resuscitation services. | All professionals in contact with children were interviewed: doctors (senior and intern), paramedics (managers, pediatric nurses, auxiliaries and nurses, psychomotor therapists) and psychologists. The survey was based on a questionnaire, which was offered to all professionals, both medical and non-medical. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the level of appropriation by neonatal resuscitation services in the Paris region of the legal devices related to the palliative approach.
The questions were designed to measure the level of training of medical and paramedical personnel on palliative and end-of-life care in the service.
Measured: Through study completion, an average of four months.
Secondary outcomes (1)
Measure the level of each death patterns in neonatal resuscitation services in the Paris region.
To measure the implementation of the limitations and shutdowns of active therapies, with particular attention to stopping artificial nutrition and hydration, as well as stopping sedation. To measure precisely this data it will be necessary to answer the questionnaire of the study. Questions about death patterns will account for the number of deaths associated with an interruption of artificial nutrition, a cessation of hydration or cessation of sedation. This will allow the data to be encrypted for use.
Measured: Through study completion, an average of four months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Jan 2016
- Primary completion1 Feb 2016
- Study completion1 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DeathStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe BOIZE, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368248
- Sponsor's protocol ID
- CHRD1415
- Acronym
- EvDPMNN
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2017
- Last updated
- 9 Jun 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Palliative Approach in the NICU
- ClinicalTrials.gov ID
- NCT03368248
- Acronym / sponsor ID
- EvDPMNN / CHRD1415
- Conditions
- Neonatal Death
- Keywords
- Palliative care, Collegial meetings, Neonatal resuscitation services, Survey, Medico-caring staff of the NICUs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 11 Dec 2017 (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 resuscitation, the majority of deaths currently occur after a Life Limitation or Discontinuance (LAT) procedure. In the 1990s, the approach was different, as Marina CUTTINI put it in a European study that highlighted some French peculiarities: doctors and nurses found it legitimate to have life stops in certain circumstances, and wanted to keep parents away from these decisions deemed guilt. Civil society has changed the thinking in recent years by the so-called Kouchner then LEONETTI laws. The palliative approach, which is defined as the search for a fair and reasonable balance, constantly reevaluated, between curative care and care of comfort and support, has become a constant concern in neonatal resuscitation services. However, we did not find a recent study that specifies in France the modalities of deaths in neonatology, especially their proportion after LAT. Also, shortly before the adoption of the CLAYES-LEONETTI law, the authors wished to make an inventory of the practices of all the neonatal intensive care units of Ile de France, one of the main centers of French fertility.
The objectives of the study were to describe the organization of collegial meetings (CR), the decision-making process and implementation of LATs, with particular attention to stopping artificial nutrition and hydration, and sedation / analgesia. The place of the parents in these different processes (gathering their opinion, information on how to withdraw life-saving treatment, leading in the event of disagreement) was also studied. Finally, some questions about euthanasia were asked, in order to measure the evolution of ideas and practices more than 15 years after EURONIC and 10 years after the LEONETTI law.
Detailed description
This is a survey carried out among all neonatal resuscitation services in the Ile-de-France region, from January 1 to 31, 2016. All professionals in contact with children were interviewed: doctors (senior and intern), paramedics (managers, pediatric nurses, auxiliaries and nurses, psychomotor therapists) and psychologists. The survey was based on a questionnaire, which was offered to all professionals, both medical and non-medical. All questions were closed, and a free comment area was proposed at the end. The questionnaire was preceded by a comment recalling the objectives of the study, the voluntary and individual nature of participation, and insisted on respect for anonymity. It consisted of 49 questions, allowing 197 possible answers. For most questions, several answers could be chosen. An additional questionnaire was sent to the heads of the services, medical and care settings. The questions sought to describe the 2014 activity (number of admissions and number of deaths, number of collegiate meetings and number of deaths resulting from an LAT), medical and paramedical staff to calculate the response rate, the existence of reflection and / or training on palliative and end-of-life care in the service, as well as the existence of a mobile team or palliative care unit in the facility.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All neonatal resuscitation services. | – | Other: SurveyAll professionals in contact with children were interviewed: doctors (senior and intern), paramedics (managers, pediatric nurses, auxiliaries and nurses, psychomotor therapists) and psychologists. The survey was based on a questionnaire, which was offered to all professionals, both medical and non-medical. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Medico-caring staff of the NICUs in the Paris region.
Key inclusion criteria (1 listed)
- medico-caring staff of the NICUs in the Paris region
Key exclusion criteria (1 listed)
- No response to the supplementary questionnaire, not allowing to assess the response rate of the center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyA survey was conducted among all professionals in neonatal resuscitation services : doctors (senior and intern), paramedics (managers, pediatric nurses, auxiliaries and nurses, psychomotor therapists) and psychologists. The survey was based on a questionnaire, which was offered to all professionals, both medical and non-medical. All questions were closed, and a free comment area was proposed at the end. The questionnaire was preceded by a comment recalling the objectives of the study, the voluntary and individual nature of participation, and insisted on respect for anonymity. It consisted of 49 questions, allowing 197 possible answers. For most questions, several answers could be chosen. | Other | All neonatal resuscitation services. |
Primary outcome
Measure the level of appropriation by neonatal resuscitation services in the Paris region of the legal devices related to the palliative approach.
Time frame: Through study completion, an average of four months.
The questions were designed to measure the level of training of medical and paramedical personnel on palliative and end-of-life care in the service.
1 secondary outcome
Measure the level of each death patterns in neonatal resuscitation services in the Paris region.
Time frame: Through study completion, an average of four months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Philippe BOIZE principal investigator
Hôpital NOVO
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 Neonatal Death, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the level of appropriation by neonatal resuscitation services in the Paris region of the legal devices related to the palliative approach. (time frame: Through study completion, an average of four months.). 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 9 Jun 2026.