Evaluation of the Palliative Approach in the NICU

NCT03368248 | Completed

• 1 other identifier: CHRD1415
• Study Type: observational
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Death

Keywords

Palliative care; Collegial meetings; Neonatal resuscitation services; Survey; Medico-caring staff of the NICUs

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Through study completion, an average of four months.

Study Arms (1)

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

Interventions

Survey OTHER

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.

All neonatal resuscitation services.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital NOVO: lead

MeSH Terms

Conditions

Perinatal Death

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Philippe BOIZE

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 11, 2017
• Study Start: January 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share