- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02580786
Breastfeeding Preterm Infants - The Efficacy of Internet-based Peer Support
October 21, 2015 updated by: Hannakaisa Niela-Vilen, University of Turku
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Not Applicable
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mothers giving birth before full 35 gestational weeks in a study hospital
Exclusion Criteria:
- 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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breastfeeding peer support
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.
|
|
No Intervention: Routine breastfeeding support
Routine breastfeeding support provided in the hospital and in the maternal and child health clinics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of breastfeeding
Time Frame: 12 months
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initiation of breastfeeding (postnatal age of the preterm infant)
Time Frame: 2 months
|
The postnatal age (days), when the preterm infant initiates breastfeeding for the first time, is measured
|
2 months
|
Duration of expressing milk
Time Frame: 12 months
|
12 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
June 1, 2011
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
October 15, 2015
First Submitted That Met QC Criteria
October 19, 2015
First Posted (Estimate)
October 20, 2015
Study Record Updates
Last Update Posted (Estimate)
October 22, 2015
Last Update Submitted That Met QC Criteria
October 21, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 26/2011
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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