NCT03323970

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
Last Updated

November 8, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

October 25, 2017

Last Update Submit

November 6, 2017

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

  • semi-structured interviews

    qualitative data analysis - theorical saturation

    3 months

Study Arms (1)

Physicians

Other: semi-structured interviews

Interventions

semi-structured interviewsOTHER

individual semi-structured interviews

Physicians

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Not fluent French speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

October 27, 2017

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 8, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share