NCT04395703

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2021

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

May 12, 2020

Last Update Submit

April 7, 2022

Conditions

Keywords

Staff experience,barriers,challenges,facilitators

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    2 years

Study Arms (2)

Maternity staff

Interviews with maternity staff working within a maternity unit including midwifery managers and infant feeding lead staff members.

Other: Interviews and focus groups

Neonatal unit staff

Staff working within a local maternity unit.

Other: Interviews and focus groups

Interventions

Unstructured and semi-structured interviews with open ended questions.

Maternity staffNeonatal unit staff

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Maternity and neonatal staff who meet the inclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • Maternity staff with no BFI experience.
  • Medical staff.
  • Community maternity staff.
  • Community nurses and health visitors.
  • Student nurses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dorset County Hospital NHS Foundation Trust

Dorchester, Dorset, DT1 2JY, United Kingdom

Location

MeSH Terms

Interventions

Interviews as TopicFocus Groups

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hazel Tennant

    Postgraduate Researcher and Midwife

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 20, 2020

Study Start

October 27, 2020

Primary Completion

October 11, 2021

Study Completion

October 11, 2021

Last Updated

April 8, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations