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Evaluation of the Palliative Approach in the NICU (EvDPMNN)

26 juli 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

61

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

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

NVT

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

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

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Measure the level of appropriation by neonatal resuscitation services in the Paris region of the legal devices related to the palliative approach.
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Measure the level of each death patterns in neonatal resuscitation services in the Paris region.
Tijdsspanne: 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.

Medewerkers en onderzoekers

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

Sponsor

Centre Hospitalier René Dubos

Onderzoekers

  • Hoofdonderzoeker: Philippe BOIZE, Centre Hospitalier Rene Dubos

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 (Werkelijk)

1 januari 2016

Primaire voltooiing (Werkelijk)

1 februari 2016

Studie voltooiing (Werkelijk)

1 april 2016

Studieregistratiedata

Eerst ingediend

24 november 2017

Eerst ingediend dat voldeed aan de QC-criteria

5 december 2017

Eerst geplaatst (Werkelijk)

11 december 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juli 2019

Laatste update ingediend die voldeed aan QC-criteria

26 juli 2019

Laatst geverifieerd

1 juli 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CHRD1415

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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