Premature BirthPRODANCT03323970
Decision Making in Neonatology : a Qualitative Study
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Besancon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- semi-structured interviews
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not fluent French speaker
About this study
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.
- Conditions
- Premature Birth
- Being tested
- semi-structured interviews
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interviewsOther
individual semi-structured interviews
| Study group | Role | What they receive |
|---|---|---|
| Physicians | Not described Receives: Other: semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
semi-structured interviews
qualitative data analysis - theorical saturation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323970
- Sponsor's protocol ID
- P/2014/219
- Acronym
- PRODA
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making in Neonatology : a Qualitative Study
- ClinicalTrials.gov ID
- NCT03323970
- Acronym / sponsor ID
- PRODA / P/2014/219
- Conditions
- Premature Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: semi-structured interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Not fluent French speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semi-structured interviewsindividual semi-structured interviews | Other | Physicians |
Primary outcome
semi-structured interviews
Time frame: 3 months
qualitative data analysis - theorical saturation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Premature Birth
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
semi-structured interviews (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.