- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03070041
The Impact of Baby-friendly Hospital Initiative to Breastfeeding, Breastfeeding Counselling and Breastfeeding Attitudes
November 5, 2020 updated by: Hannakaisa Niela-Vilen, University of Turku
Vauvamyönteisyysohjelman Vaikutus Imetykseen, Imetysohjaukseen ja Imetysasenteisiin / The Impact of Baby-friendly Hospital Initiative to Breastfeeding, Breastfeeding Counselling and Breastfeeding Attitudes
The impact of Baby-friendly Hospital Initiative (BFHI) to breastfeeding, breastfeeding counselling and breastfeeding attitudes will be examined in Satakunta Central Hospital, Finland.
The baseline measurement will be conducted before the implementation of BFHI in 2017 and second measurement will be conducted in 2019 after the certification process.
Both staff members and breastfeeding mothers will be recruited in the study.
The main outcomes are the duration of breastfeeding and breastfeeding attitudes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
425
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Pori, Finland
- Satasairaala Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Staff: All staff members taking care of mothers and/or infants in the hospital.
- Mothers: Mothers who have given birth in the study hospital during the data collection period.
Exclusion Criteria:
Mothers:
- who have given birth outside the hospital,
- whose infant's condition is critical,
- whose infants are transferred to another unit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mothers and staff members
The mothers who will give birth at the study hospital and all the staff members taking care about mothers and/or infants
|
The intervention is Baby-friendly Hospital Initiative as described by WHO and UNICEF.
The ten steps to successful breastfeeding will be implemented in the hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of breastfeeding
Time Frame: Six months
|
Duration of breastfeeding will be asked from the mother
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Six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding attitude of the staff (questionnaire)
Time Frame: Two years
|
Attitude will be measured with a structured questionnaire
|
Two years
|
Breastfeeding attitude of the mothers (questionnaire)
Time Frame: Four months
|
Attitude will be measured with a structured and validated questionnaire
|
Four months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2017
Primary Completion (ACTUAL)
February 28, 2020
Study Completion (ACTUAL)
February 28, 2020
Study Registration Dates
First Submitted
February 28, 2017
First Submitted That Met QC Criteria
March 2, 2017
First Posted (ACTUAL)
March 3, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 6, 2020
Last Update Submitted That Met QC Criteria
November 5, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Satavamy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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