Experience, LifeNCT04395703
Baby Friendly Initiative Implementation: Maternity Staff Experiences
An observational study of Experience, Life, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
This qualitative, case study will explore the experiences of maternity staff in England when implementing the World Health Organisation and Unicef Baby Friendly Initiative (BFI) standards within a maternity organisation. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Experience, Life
- What is being tested?
- Interviews and focus groups
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2020to 11 Oct 2021
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Maternity and neonatal staff who meet the inclusion criteria.
Who may be able to join
- Maternity staff who have had training in and with experience of working with the BFI.
- Senior neonatal staff working in the maternity unit.
- Maternity unit management.
- Staff in specialised infant feeding roles at local hospitals.
- Student midwives on placement at main study hospital site.
- English speaking.
Who cannot join
- Maternity staff with no BFI experience.
- Medical staff.
- Community maternity staff.
- Community nurses and health visitors.
- Student nurses.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, DT1 2JY
About this study
Official title: Barriers, Challenges and Facilitators for the Unicef Baby Friendly Initiative (BFI): A Qualitative Study of Maternity Staff Experiences
This qualitative, case study will explore the experiences of maternity staff in England when implementing the World Health Organisation and Unicef Baby Friendly Initiative (BFI) standards within a maternity organisation.
Read the detailed description
A range of maternity staff over 4 UK NHS hospitals will be recruited and interviewed by one chief investigator regarding their experiences of working with the BFI standards in their daily professional practice.
- Conditions
- Experience, Life
- Being tested
- Interviews and focus groups
- Keywords
- Staff experience,barriers,challenges,facilitators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews and focus groupsOther
Unstructured and semi-structured interviews with open ended questions.
| Study group | Role | What they receive |
|---|---|---|
| Maternity staff | Interviews with maternity staff working within a maternity unit including midwifery managers and infant feeding lead staff members. Receives: Other: Interviews and focus groups | |
| Neonatal unit staff | Staff working within a local maternity unit. Receives: Other: Interviews and focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify barriers to the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.
The aim is to identify themes regarding barriers that are in place when implementing policies into maternity organisations. These will be developed into recommendations which managers and policy makers can utilise to enable change management.
Measured: 2 years
To identify challenges to the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.
The aim is to identify themes regarding the challenges that are in place when implementing policies into maternity organisations. These will be developed into recommendations which managers and policy makers can utilise to enable change management.
Measured: 2 years
To identify what facilitates the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.
The aim is to identify themes regarding the facilitators when implementing the Unicef Baby Friendly Initiative into maternity organisations. These will be developed into recommendations which managers and policy makers can utilise to enable change management.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start27 Oct 2020
- Primary completion11 Oct 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Experience, LifeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Dorset County Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Hazel Tennant, Principal investigator, Postgraduate Researcher and Midwife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395703
- Sponsor's protocol ID
- 274438
- Status last verified
- Apr 2022
- First submitted
- 12 May 2020
- Last updated
- 8 Apr 2022
- Results posted
- 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers, Challenges and Facilitators for the Unicef Baby Friendly Initiative (BFI): A Qualitative Study of Maternity Staff Experiences
- ClinicalTrials.gov ID
- NCT04395703
- Acronym / sponsor ID
- 274438
- Conditions
- Experience, Life
- Keywords
- Staff experience,barriers,challenges,facilitators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Dorset County Hospital NHS Foundation Trust
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 20 May 2020 (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 qualitative, case study will explore the experiences of maternity staff in England when implementing the World Health Organisation and Unicef Baby Friendly Initiative (BFI) standards within a maternity organisation.
Detailed description
A range of maternity staff over 4 UK NHS hospitals will be recruited and interviewed by one chief investigator regarding their experiences of working with the BFI standards in their daily professional practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternity staff | – | Other: Interviews and focus groupsInterviews with maternity staff working within a maternity unit including midwifery managers and infant feeding lead staff members. |
| Neonatal unit staff | – | Other: Interviews and focus groupsStaff working within a local maternity unit. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Maternity and neonatal staff who meet the inclusion criteria.
Key inclusion criteria (6 listed)
- Maternity staff who have had training in and with experience of working with the BFI.
- Senior neonatal staff working in the maternity unit.
- Maternity unit management.
- Staff in specialised infant feeding roles at local hospitals.
- Student midwives on placement at main study hospital site.
Key exclusion criteria (5 listed)
- Maternity staff with no BFI experience.
- Medical staff.
- Community maternity staff.
- Community nurses and health visitors.
- Student nurses.
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 |
|---|---|---|
| Interviews and focus groupsUnstructured and semi-structured interviews with open ended questions. | Other | Maternity staff, Neonatal unit staff |
Primary outcome
To identify barriers to the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.
Time frame: 2 years
The aim is to identify themes regarding barriers that are in place when implementing policies into maternity organisations. These will be developed into recommendations which managers and policy makers can utilise to enable change management.
To identify challenges to the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.
Time frame: 2 years
The aim is to identify themes regarding the challenges that are in place when implementing policies into maternity organisations. These will be developed into recommendations which managers and policy makers can utilise to enable change management.
To identify what facilitates the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.
Time frame: 2 years
The aim is to identify themes regarding the facilitators when implementing the Unicef Baby Friendly Initiative into maternity organisations. These will be developed into recommendations which managers and policy makers can utilise to enable change management.
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 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Hazel Tennant principal investigator
Postgraduate Researcher and Midwife
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 Experience, Life, run by Bournemouth University at 1 site in United Kingdom.
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 6 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: finished, as of the sponsor's last update on 8 Apr 2022. 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 United Kingdom. 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?
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?
To identify barriers to the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation. (time frame: 2 years). The study lists 3 primary outcomes in all. 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 Apr 2022.