Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03368248
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2017-11-24
Brief Title:
Evaluation of the Palliative Approach in the NICU
Sponsor:
Hôpital NOVO
Organization:
Hôpital NOVO
Study Overview
Official Title:
Evaluation of the Palliative Approach in the NICU
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EvDPMNN
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None