Preterm BirthNCT07709663
The Effect of Web-Based Counselling on Breastfeeding Experiences and Infant Care Competence Among Mothers of Preterm Babies
A study testing Web-Based Breastfeeding Counseling and Infant Care Program in people with Preterm Birth, run by Medipol University.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Web-Based Breastfeeding Counseling and Infant Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Web-Based Breastfeeding Counseling and Infant Care Program, control group
- Keywords
- Web-based consulting, breast milk pumping, infant care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Breastfeeding Counseling and Infant Care ProgramBehavioural
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.
control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| response team | Experimental | 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. Receives: Behavioral: Web-Based Breastfeeding Counseling and Infant Care Program |
| control group | Active comparator | 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Tool for Measuring the Caregiving Competence of Mothers of Premature Infants (CUIDAR-MaPre)
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."
Measured: one month
Breast Milk Expression Experience Scale
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned to either the intervention group or the control group in a 1:1 ratio. Participants assigned to the intervention group will receive a web-based breastfeeding counseling and premature infant care education program in addition to routine care; participants assigned to the control group will receive only the routine care provided by the hospital. Participants will remain in the group to which they were assigned for the duration of the study, and there will be no switching between groups.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abide Başpınar, Medipol University
- Investigators
- Abide Başpınar, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709663
- Sponsor's protocol ID
- 2025/1658
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 21 Jul 2026
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Counselling on Breastfeeding Experiences and Infant Care Competence Among Mothers of Preterm Babies
- ClinicalTrials.gov ID
- NCT07709663
- Acronym / sponsor ID
- 2025/1658
- Conditions
- Preterm Birth
- Keywords
- Web-based consulting, breast milk pumping, infant care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 16 Jul 2026 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intervention group or the control group in a 1:1 ratio. Participants assigned to the intervention group will receive a web-based breastfeeding counseling and premature infant care education program in addition to routine care; participants assigned to the control group will receive only the routine care provided by the hospital. Participants will remain in the group to which they were assigned for the duration of the study, and there will be no switching between groups.
| Arm | Type | Receives |
|---|---|---|
| response team | Experimental | Behavioral: Web-Based Breastfeeding Counseling and Infant Care ProgramParticipants 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. |
| control group | Active comparator | Other: control groupParticipants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Web-Based Breastfeeding Counseling and Infant Care ProgramParticipants 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. | Behavioural | response team |
| control groupParticipants 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. | Other | control group |
Primary outcome
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."
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Abide Başpınar principal investigator
Medipol University
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Breastfeeding Counseling and Infant Care Program in people with Preterm Birth, run by Medipol University.
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 6 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: opening soon, as of the sponsor's last update on 21 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abide Başpınar (05496265477, abidebaspinar4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Tool for Measuring the Caregiving Competence of Mothers of Premature Infants (CUIDAR-MaPre) (time frame: one month). 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 21 Jul 2026.