Decision Making in Neonatology : a Qualitative Study (PRODA)

November 6, 2017 updated by: Centre Hospitalier Universitaire de Besancon
This study aimed to describe and understand the decision making process in neonatology in situations of limiting of withdraw life sustaining treatments, by conducting interviews with physicians from one neonatology unit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study concerns the situation of new born for whom a decision making regarding limiting or withdrawing treatments is emerging, but only the physicians are involved as subjects of the study and seen in interviews.

Description

Inclusion Criteria:

  • Physicians in charge of new born babies for whom a decision making regarding limiting or withdrawing treatments is emerging.
  • physicians' informed consent to participate to an interview
  • parents' informed consent to collect data concerning their new born.

Exclusion Criteria:

- Not fluent French speaker

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
Intervention / Treatment
Physicians
Other: semi-structured interviews
individual semi-structured interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
semi-structured interviews
Time Frame: 3 months
qualitative data analysis - theorical saturation
3 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

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)

November 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (ACTUAL)

October 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2014/219

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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