Breast FeedingNCT02580786
Breastfeeding Preterm Infants - The Efficacy of Internet-based Peer Support
A study testing Breastfeeding peer support in people with Breast Feeding and Infant, Premature, run by University of Turku.
Trial summary
This study examines if the internet-based peer support has an effect on the breastfeeding attitude or the duration of breastfeeding in preterm infants and their mothers compared with mothers with routine care. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Infant, Premature
- What is being tested?
- Breastfeeding peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to May 2015
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers giving birth before full 35 gestational weeks in a study hospital
Who cannot join
- The mother not able to speak Finnish
- The infant's condition is critical (based on the paediatrician),
- The mother has a syndrome or illness preventing breastfeeding
About this study
This study examines if the internet-based peer support has an effect on the breastfeeding attitude or the duration of breastfeeding in preterm infants and their mothers compared with mothers with routine care. The factors associated with the initiation of breastfeeding in the neonatal intensive care unit will be determined. In addition, the perceptions of the mothers of preterm infants about their needs and problems when breastfeeding their preterm infants are described.
- Conditions
- Breast Feeding, Infant, Premature
- Being tested
- Breastfeeding peer support
- Medical subject headings
- Breast Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding peer supportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding peer support | Experimental | Internet-based breastfeeding peer-support group in social media (Facebook). The mothers are allowed to use the group based on their individual needs from the recruitment to the first birthday of their child. Peer support is provided by three voluntary mothers. The mothers can discuss breastfeeding-related issues and ask questions. A midwife will moderate the group. Receives: Behavioral: Breastfeeding peer support |
| Routine breastfeeding support | No intervention | Routine breastfeeding support provided in the hospital and in the maternal and child health clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of breastfeeding
Measured: 12 months
Breastfeeding attitude with Iowa Infant Feeding Attitude Scale
Iowa Infant Feeding Attitude Scale (IIFAS) is used to measure breastfeeding attitude
Measured: 6 months
Secondary outcomes (2)
Initiation of breastfeeding (postnatal age of the preterm infant)
The postnatal age (days), when the preterm infant initiates breastfeeding for the first time, is measured
Measured: 2 months
Duration of expressing milk
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJun 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 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
- NCT02580786
- Sponsor's protocol ID
- 26/2011
- Status last verified
- Oct 2015
- First submitted
- 15 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding Preterm Infants - The Efficacy of Internet-based Peer Support
- ClinicalTrials.gov ID
- NCT02580786
- Acronym / sponsor ID
- 26/2011
- Conditions
- Breast Feeding, Infant, Premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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 study examines if the internet-based peer support has an effect on the breastfeeding attitude or the duration of breastfeeding in preterm infants and their mothers compared with mothers with routine care. The factors associated with the initiation of breastfeeding in the neonatal intensive care unit will be determined. In addition, the perceptions of the mothers of preterm infants about their needs and problems when breastfeeding their preterm infants are described.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding peer support | Experimental | Behavioral: Breastfeeding peer supportInternet-based breastfeeding peer-support group in social media (Facebook). The mothers are allowed to use the group based on their individual needs from the recruitment to the first birthday of their child. Peer support is provided by three voluntary mothers. The mothers can discuss breastfeeding-related issues and ask questions. A midwife will moderate the group. |
| Routine breastfeeding support | No intervention | –Routine breastfeeding support provided in the hospital and in the maternal and child health clinics |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers giving birth before full 35 gestational weeks in a study hospital
Key exclusion criteria (3 listed)
- The mother not able to speak Finnish
- The infant's condition is critical (based on the paediatrician),
- The mother has a syndrome or illness preventing breastfeeding
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 |
|---|---|---|
| Breastfeeding peer support | Behavioural | Breastfeeding peer support |
Primary outcome
Duration of breastfeeding
Time frame: 12 months
Breastfeeding attitude with Iowa Infant Feeding Attitude Scale
Time frame: 6 months
Iowa Infant Feeding Attitude Scale (IIFAS) is used to measure breastfeeding attitude
2 secondary outcomes
Initiation of breastfeeding (postnatal age of the preterm infant)
Time frame: 2 months
Duration of expressing milk
Time frame: 12 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 22 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding peer support in people with Breast Feeding and Infant, Premature, run by University of Turku.
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 1 inclusion and 3 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 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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: 12 months). The study lists 2 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 22 Oct 2015.