- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883866
Phone Breastfeeding Support for Premature Babies
July 20, 2021 updated by: Ezgi Boz, Akdeniz University
Impact of Telephone Breastfeeding Support on Breastfeeding Outcomes for Mothers With Premature Babies: Randomized Controlled Study
It was observed that premature babies had the risk of insufficient milk intake and a lower rate of breastfeeding compared to term babies.
Various problems may occur at home, especially after breastfeeding training in the hospital.
After discharge, support and counseling should be provided to eliminate problems that may stop breastfeeding or to prevent events that may prevent breastfeeding.
The aim of this study is to examine the effect of "Telephone Breastfeeding Support" given to mothers of premature babies discharged from the neonatal intensive care unit on breastfeeding results.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The study was planned as a randomized, parallel two-group, controlled experimental design.
This research will be conducted between June 2021 and June 2022 with premature baby mothers.
The sample of the study will be mothers (n = 62) of premature babies discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit.
The discharge routine procedures of all mothers participating in the study will be completed and a breastfeeding guide prepared for premature babies will be sent to the phone.
On the 3rd day after discharge, a reminder message will be sent to support the mother in the intervention group (n = 31) and to encourage breast milk.
Throughout the program, 21 messages will be sent to the mothers in the first month after discharge, via the messaging application (whatsapp, bip, telegram, etc.)
In addition, seven phone calls will be made once a week in the first month after discharge, and once a month in the eighth, twelfth and sixteenth weeks.
Data will be collected by Mother-Baby Introductory Information Form, Breastfeeding Self-Efficacy Scale (short form) (BSES), Infant Feeding Attitude Scale (IIFAS) and Breastfeeding Time Assessment Form.
The pre-test will be taken with the Mother-Baby Descriptive Information Form, BSES and IIFAS during the discharge routine procedures, and the post-test will be taken with the BSES, IIFAS and Breastfeeding Time Assessment Form when the baby is six months old.
Ethics Committee and Institutional Permission was obtained for the study.
In addition, written consent will be obtained from the participants.
Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p <0.05.
Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University.
It is anticipated that new information from research data will improve breastfeeding results of premature babies and guide new research.
Study Type
Interventional
Enrollment (Anticipated)
62
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 Contact
- Name: Ezgi Boz, Postgraduate
- Phone Number: +905398578928
- Email: ezgi.boz96@gmail.com
Study Contact Backup
- Name: Arzu Akcan, PhD
- Phone Number: +902423106108 +905334436659
- Email: aarzu@akdeniz.edu.tr
Study Locations
-
-
-
Antalya, Turkey, 07000
- Recruiting
- Akdeniz University
-
-
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:
- Whose baby was born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
- Does not have severe congenital anomalies in her baby (according to hospital records),
- Breastfeeding her baby,
- Reading and writing,
- Can speak and understand Turkish,
- Mothers who agreed to participate in the study,
- Mothers having a smartphone.
Exclusion Criteria:
- Mothers with previous experience of breastfeeding a premature baby,
- Plural baby,
- Mother's breastfeeding disability (according to hospital records).
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Sending breastfeeding guidelines for premature babies to phones after the discharge procedure is completed.and
implementing a "Telephone Breastfeeding Support Program".
|
On the 3rd day after discharge, a reminder messages will be sent to the mothers in the inter vention group.
Throughout the program, 21 reminder messages will be sent to mothers in the first month after discharge to support the mother and encourage breast milk via a messaging application (whatsapp, bip, telegram, etc.).
In addition, a total of seven phone calls, once a week in the first month after discharge and once a month in the eighth, twelfth and sixteenth weeks, will be made to check personalized information about individual breastfeeding questions of mothers.
In addition to the routine discharge procedure, a breastfeeding guide for premature babies will be sent to the mothers' phone.
|
Experimental: Control Group
Sending breastfeeding guidelines for premature babies to phones after the discharge procedure is completed.
|
In addition to the routine discharge procedure, a breastfeeding guide for premature babies will be sent to the mothers' phone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding Self-Efficacy Scale (short form)
Time Frame: 0-6 months (During discharge routine procedures and when the baby is six months old)
|
The scale, which is valid and reliable in our country by Aluş Tokat, Okun and Dennis (2010), consists of 14 items and is a Likert type scale rated between 1 and 5.
The minimum score that can be retrieved from the scale is 14 and the maximum is 70.
As the score rises, high breastfeeding is an indicator of self-sufficiency.
|
0-6 months (During discharge routine procedures and when the baby is six months old)
|
Infant Feeding Attitude Scale
Time Frame: 0-6 months (During discharge routine procedures and when the baby is six months old)
|
The scale was developed to evaluate women's attitudes towards breastfeeding and to predict breastfeeding duration as well as the choice of baby feeding method.
The scale consists of 5-point Likert type and 17 items.
The total attitude score ranges from 17 (showing a positive attitude to bottle feeding) to 85 (reflecting a positive attitude towards breastfeeding).
The higher the score on the scale, the higher it indicates the higher breastfeeding attitude.
|
0-6 months (During discharge routine procedures and when the baby is six months old)
|
3. Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form
Time Frame: When the baby is six months old
|
Prepared by researcher to find out breastfeeding status when babies are 6 months old.
|
When the baby is six months old
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Arzu Akcan, PhD, +905334436659
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)
June 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
May 7, 2021
First Submitted That Met QC Criteria
May 7, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 20, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK- 118
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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