PrematurityVINCINCT04852094
Family-centered Round in Neonatology
An observational study of Prematurity, run by University Hospital, Brest at 1 site in France.
Trial summary
The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prematurity
- What is being tested?
- Qualitative focus group
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 31 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Parents group: age, parity, education and income level Staff group: age, gender, years of experience in the NICU, profession
Who may be able to join
- French speaking
- voluntary to participate
- parents of an hospitalized newborn
Who cannot join
- not fluent in French speaking
- mental health problems
- Professional group:
- any staff member
- voluntary to participate
Trial locations and contacts
1 site in 1 country.
Jean-Michel Roue, MD, Phd contact
France1 site
CHRU de Brest
Brest, 29609
Jean-Michel ROUE, jean-michel.roue@chu-brest.fr
About this study
Official title: Family-centered Round in Neonatal Units : Process Development and Implementation Using the Intervention Mapping
The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination
- Conditions
- Prematurity
- Being tested
- Qualitative focus group
- Keywords
- Newborn, Preterm, medical round, family-centered care, NICU
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative focus groupOther
A qualitative focus group is performed with staff members and parents of hospitalised newborns in a NICU during Family-centered rounds management. The transcribed interviews are analyzed with qualitative content analysis in order to illuminate the experience, feelings and thoughts arisen among the staff members and the parents.
| Study group | Role | What they receive |
|---|---|---|
| Parents | parents of hospitalized children, speaking and understanding enough French, not presenting psychiatric disorders, voluntary to participate in focus groups Receives: Other: Qualitative focus group | |
| Professionals | Nurses, assistant nurses, psychologist, physiotherapist, physicians, residents and fellows Receives: Other: Qualitative focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of participating to a Family-Centered Care (FCR)
Qualitative focus group interview performed at one occasion where the parent describes the experience of the FCR
Measured: 1 day during the last week of their newborn 'hospitalisation
Secondary outcomes (1)
Experience of staff members in participating to a (FCR)
Qualitative focus group interview performed at one occasion where the staff members describes the experience of the FCR
Measured: 1 day after 3 months of FCR experience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Sizun, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852094
- Sponsor's protocol ID
- VINCI
- Acronym
- VINCI
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-centered Round in Neonatal Units : Process Development and Implementation Using the Intervention Mapping
- ClinicalTrials.gov ID
- NCT04852094
- Acronym / sponsor ID
- VINCI / VINCI
- Conditions
- Prematurity
- Keywords
- Newborn, Preterm, medical round, family-centered care, NICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Apr 2021 (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.
The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: Qualitative focus groupparents of hospitalized children, speaking and understanding enough French, not presenting psychiatric disorders, voluntary to participate in focus groups |
| Professionals | – | Other: Qualitative focus groupNurses, assistant nurses, psychologist, physiotherapist, physicians, residents and fellows |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents group: age, parity, education and income level Staff group: age, gender, years of experience in the NICU, profession
Key inclusion criteria (3 listed)
- French speaking
- voluntary to participate
- parents of an hospitalized newborn
Key exclusion criteria (5 listed)
- not fluent in French speaking
- mental health problems
- any staff member
- voluntary to participate
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 |
|---|---|---|
| Qualitative focus groupA qualitative focus group is performed with staff members and parents of hospitalised newborns in a NICU during Family-centered rounds management. The transcribed interviews are analyzed with qualitative content analysis in order to illuminate the experience, feelings and thoughts arisen among the staff members and the parents. | Other | Parents, Professionals |
Primary outcome
Experience of participating to a Family-Centered Care (FCR)
Time frame: 1 day during the last week of their newborn 'hospitalisation
Qualitative focus group interview performed at one occasion where the parent describes the experience of the FCR
1 secondary outcome
Experience of staff members in participating to a (FCR)
Time frame: 1 day after 3 months of FCR experience
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
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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.
Jean-Michel Roue, MD, Phd contact
Jacques Sizun principal investigator
University Hospital, Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity, run by University Hospital, Brest at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques Sizun, MD (+33561776280, sizun.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of participating to a Family-Centered Care (FCR) (time frame: 1 day during the last week of their newborn 'hospitalisation). 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 21 Apr 2021.