- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07709663
The Effect of Web-Based Counselling on Breastfeeding Experiences and Infant Care Competence Among Mothers of Preterm Babies
Breast milk is of great importance for preterm infants in terms of optimal growth, immune system development, and neurodevelopment. However, mothers who give birth prematurely may face various challenges during the breastfeeding process due to their infants' need for monitoring in the neonatal intensive care unit, mother-infant separation, and the need to pump breast milk. This situation can negatively affect the experience of expressing breast milk and the mother's perception of her competence in caring for her baby.
The aim of this randomized controlled trial is to evaluate the effect of web-based breastfeeding counseling on the breast milk expression experience and the competence in caring for a preterm infant among mothers of preterm infants. A total of 56 mothers who gave birth preterm at 30 weeks of gestation or later and whose infants are being monitored in the neonatal intensive care unit will be included in the study. Participants will be randomly assigned to the intervention and control groups.
Mothers in the intervention group will have access to a Moodle-based training program that includes video training on breastfeeding counseling and care for premature infants, as well as the opportunity to ask the researcher questions online. Mothers in the control group, on the other hand, will continue to receive the hospital's routine education and care services.
The primary outcome measures of the study will be assessed using the Breastfeeding Experience Scale and the Premature Infant Care Competence Assessment Tool. Measurements will be taken at the start of the study, following the training, and at the end of the one-month follow-up period to examine the effect of web-based counseling on mothers' breastfeeding experience and care competence.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For preterm infants, breast milk is the most important source of nutrition for optimal growth, immune system development, and neurodevelopment. However, mothers who give birth prematurely may face various challenges during the breastfeeding process due to separation from their baby, the baby's admission to the neonatal intensive care unit, the need to pump breast milk, and the physical and psychosocial difficulties experienced after childbirth. This situation can affect the maintenance of breast milk production, the pumping experience, and mothers' confidence in caring for their preterm babies. Today, digital health applications support continuity of care by providing mothers with education and counseling during the postpartum period, independent of time and location. However, evidence evaluating the impact of web-based breastfeeding counseling for mothers of preterm infants on their breast milk expression experience and caregiving competence is limited.
This study is a randomized controlled experimental study designed to evaluate the effect of web-based breastfeeding counseling on the breast milk expression experience and caregiving competence of mothers of preterm infants. The study will include a total of 56 mothers who have given birth prematurely at 30 or more weeks of gestation, whose infants are being monitored in a neonatal intensive care unit, who are first-time mothers, and who have voluntarily agreed to participate in the study. Participants will be randomly assigned to the intervention and control groups.
Mothers in the intervention group will receive breastfeeding counseling and training on the care of premature infants via a Moodle-based online training platform. The training program will consist of short, hands-on instructional videos covering topics such as the importance of breast milk for premature infants, milk expression methods, breast milk storage, maintaining breastfeeding, managing common breastfeeding challenges, kangaroo care, daily care of premature infants, and post-discharge care. Participants will be able to access the educational materials at any time and contact the researcher online to ask questions.
Mothers in the control group, on the other hand, will continue to receive the standard breastfeeding education and routine care services provided at the hospital throughout the study. Data will be collected from both groups at baseline, after the intervention, and at the end of the one-month follow-up period. The Breast Milk Expression Experience Scale and the Premature Infant Care Competency Assessment Tool will be used to evaluate the results.
The aim of this study is to provide evidence on the impact of digital breastfeeding counseling and infant care for mothers of preterm infants on their breast milk expression experience and caregiving competence, and to contribute to the development of sustainable remote counseling models following discharge from the neonatal intensive care unit.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abide Başpınar
- Phone Number: 05496265477
- Email: abidebaspinar4@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To be a first-time mother (primipara).
- To have had a preterm birth at 30 weeks or more of gestation.
- For the baby to be hospitalized in the neonatal intensive care unit.
- For the newborn to have no medical condition that prevents breastfeeding.
- To be able to read and understand Turkish.
- To be willing to participate in the study.
Exclusion Criteria:
- Mothers with a medical condition contraindicating breastfeeding.
- Infants with a major congenital anomaly or medical condition preventing breast milk feeding.
- Withdrawal of consent or inability to complete follow-up assessments.
Study Plan
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: response team
Participants assigned to the experimental group will receive a web-based breastfeeding counseling and preterm infant care education program delivered through a Moodle-based platform in addition to routine hospital care.
The program includes educational videos on breastfeeding, breast milk expression, breast milk storage, kangaroo care, management of common breastfeeding problems, preterm infant care, and post-discharge care.
Participants will have continuous access to the educational materials throughout the study and may communicate with the researcher through the platform when needed.
|
Participants assigned to the intervention group will receive a web-based breastfeeding counseling program delivered through a Moodle-based platform in addition to routine hospital care.
The program includes evidence-based educational videos on breastfeeding, breast milk expression techniques, breast milk storage, kangaroo care, management of common breastfeeding problems, preterm infant care, and post-discharge care.
Participants may access the educational materials at any time during the study and communicate with the researcher through the platform for counseling and support.
|
|
Active Comparator: control group
Participants assigned to the control group will receive the routine breastfeeding education and standard postpartum care provided by the hospital.
They will not receive the web-based breastfeeding counseling program during the study period.
|
Participants assigned to the control group will receive the standard postpartum care and routine breastfeeding education provided by the hospital.
No additional web-based breastfeeding counseling or educational program will be provided during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A Tool for Measuring the Caregiving Competence of Mothers of Premature Infants (CUIDAR-MaPre)
Time Frame: one month
|
The scale consists of 32 items across 7 subdimensions.
The maximum possible score on the scale is 128; scores of 64 or below indicate low care competence, scores between 65 and 102 indicate moderate care competence, and scores of 103 or higher indicate high care competence.
There are no reverse-scored items on the scale.
Responses are almost never rated as "1," rarely as "2," frequently as "3," and almost always as "4."
|
one month
|
|
Breast Milk Expression Experience Scale
Time Frame: one month
|
The scale consists of 11 items and three subscales.
The lowest possible score on the scale is 1, and the highest is 5.
When the mean total score on the scale is less than 3, mothers' breast-milk expression experience is considered negative; when it is higher than 3, it is considered positive.
The scale consists of the subdimensions of social support, personal experience, and learning experience.
Item 7 on the scale is reverse-coded.
The scale's Cronbach's alpha value is 0.82.
|
one month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abide Başpınar, Medipol University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/1658
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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