BreastfeedingNCT03070041
The Impact of Baby-friendly Hospital Initiative to Breastfeeding, Breastfeeding Counselling and Breastfeeding Attitudes
A study testing Baby-friendly Hospital Initiative in people with Breastfeeding, run by University of Turku at 1 site in Finland.
Trial summary
The impact of Baby-friendly Hospital Initiative (BFHI) to breastfeeding, breastfeeding counselling and breastfeeding attitudes will be examined in Satakunta Central Hospital, Finland. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Baby-friendly Hospital Initiative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteFinland
- Study dates
- 1 Apr 2017to 28 Feb 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mothers:
- who have given birth outside the hospital,
- whose infant's condition is critical,
- whose infants are transferred to another unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breastfeeding
- Being tested
- Baby-friendly Hospital Initiative
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby-friendly Hospital InitiativeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mothers and staff members | Experimental | The mothers who will give birth at the study hospital and all the staff members taking care about mothers and/or infants Receives: Other: Baby-friendly Hospital Initiative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of breastfeeding
Duration of breastfeeding will be asked from the mother
Measured: Six months
Secondary outcomes (2)
Breastfeeding attitude of the staff (questionnaire)
Attitude will be measured with a structured questionnaire
Measured: Two years
Breastfeeding attitude of the mothers (questionnaire)
Attitude will be measured with a structured and validated questionnaire
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Apr 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannakaisa Niela-Vilen, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070041
- Sponsor's protocol ID
- Satavamy
- Status last verified
- Nov 2020
- First submitted
- 28 Feb 2017
- Last updated
- 6 Nov 2020
- 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 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vauvamyönteisyysohjelman Vaikutus Imetykseen, Imetysohjaukseen ja Imetysasenteisiin / The Impact of Baby-friendly Hospital Initiative to Breastfeeding, Breastfeeding Counselling and Breastfeeding Attitudes
- ClinicalTrials.gov ID
- NCT03070041
- Acronym / sponsor ID
- Satavamy
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 3 Mar 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mothers and staff members | Experimental | Other: Baby-friendly Hospital InitiativeThe mothers who will give birth at the study hospital and all the staff members taking care about mothers and/or infants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Mothers:
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 |
|---|---|---|
| Baby-friendly Hospital InitiativeThe intervention is Baby-friendly Hospital Initiative as described by WHO and UNICEF. The ten steps to successful breastfeeding will be implemented in the hospital. | Other | Mothers and staff members |
Primary outcome
Duration of breastfeeding
Time frame: Six months
Duration of breastfeeding will be asked from the mother
2 secondary outcomes
Breastfeeding attitude of the staff (questionnaire)
Time frame: Two years
Breastfeeding attitude of the mothers (questionnaire)
Time frame: Four months
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 6 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby-friendly Hospital Initiative in people with Breastfeeding, run by University of Turku at 1 site in Finland.
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 2 inclusion and 4 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 6 Nov 2020. 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 Finland. 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?
Duration of breastfeeding (time frame: Six 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 6 Nov 2020.