Evaluation of the Palliative Approach in the NICU (EvDPMNN)

July 26, 2019 updated by: Centre Hospitalier René Dubos

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medico-caring staff of the NICUs in the Paris region.

Description

Inclusion Criteria:

  • medico-caring staff of the NICUs in the Paris region

Exclusion Criteria:

  • No response to the supplementary questionnaire, not allowing to assess the response rate of the center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Survey
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of four months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
Through study completion, an average of four months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier René Dubos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe BOIZE, Centre Hospitalier René Dubos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHRD1415

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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