Nurse's RoleNCT06652386
Nurse-Led Telemedicine Versus In-Person Lactation Support for Breastfeeding Initiation of Low-Birth-Weight Infants
A study testing Telemedicine Group in people with Nurse's Role and Telemedicine, run by Jouf University at 1 site in Egypt.
Trial summary
Breastfeeding initiation among mothers of low birth weight (LBW) infants is crucial for neonatal health but poses significant challenges. This randomized controlled trial aims to compare the effectiveness of nursing-led telemedicine lactation support versus in-person lactation support on breastfeeding initiation rates… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Nurse's Role, Telemedicine, Lactation
- What is being tested?
- Telemedicine Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 24 Feb 2025
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mothers aged ≥18 years.
- Mothers of infants with a birth weight <2,500 grams.
- Mothers intend to breastfeed.
- Access to a smartphone, tablet, or computer with internet capability for the telemedicine group.
Who cannot join
- Infants with congenital anomalies affecting feeding.
- Mothers with medical conditions contraindicating breastfeeding.
- Non-English-speaking mothers (due to resource limitations).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-Led Telemedicine Versus In-Person Lactation Support for Breastfeeding Initiation in Mothers of Low-Birth-Weight Infants: A Non-inferiority Randomized Controlled Trial.
Breastfeeding initiation among mothers of low birth weight (LBW) infants is crucial for neonatal health but poses significant challenges. This randomized controlled trial aims to compare the effectiveness of nursing-led telemedicine lactation support versus in-person lactation support on breastfeeding initiation rates in mothers of LBW infants. The study will utilize validated tools such as the LATCH scoring system, the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), and the State-Trait Anxiety Inventory (STAI) to assess outcomes. By evaluating these two modalities, the research seeks to inform best practices for lactation support, particularly in settings where in-person care is limited.
Read the detailed description
Breastfeeding offers unparalleled health benefits for infants and mothers, including optimal nutrition, immune protection, and enhanced bonding. These benefits are especially critical for low-birth-weight infants, who are at increased risk for morbidity and mortality. Despite the recognized importance, mothers of low birth weight (LBW) infants often face barriers to initiating and maintaining breastfeeding due to factors such as neonatal intensive care unit (NICU) admissions, maternal stress, and lack of specialized support.
Telemedicine in Lactation Support Telemedicine has emerged as a promising avenue for delivering healthcare services, including lactation support. It offers increased accessibility and convenience, particularly for mothers who may face challenges attending in-person consultations. While telemedicine has been successfully implemented in various healthcare domains, its effectiveness compared to traditional in-person lactation support requires further investigation, particularly among mothers of LBW infants.
Nurses play a pivotal role in providing education, emotional support, and practical assistance to breastfeeding mothers.Understanding how nursing interventions can be optimized in telemedicine versus in-person settings is essential for enhancing breastfeeding initiation.
Objectives
- To compare breastfeeding initiation rates between mothers receiving telemedicine lactation support and those receiving in-person support.
- To assess changes in breastfeeding self-efficacy using the BSES-SF.
- To evaluate maternal satisfaction with the mode of lactation support received.
- To measure maternal anxiety and stress levels using the STAI.
- To monitor infant growth parameters up to 3 months postpartum.
- Conditions
- Nurse's Role, Telemedicine, Lactation, Breastfeeding, Low Birth Weight Infants
- Being tested
- Telemedicine Group
- Keywords
- Nurse's Role, Telemedicine, Lactation, Breastfeeding, Low Birth Weight infants
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine GroupOther
- Nursing-led lactation support via secure video conferencing platforms (e.g., Zoom for Healthcare).
- Scheduled sessions at postpartum days 1, 3, 7, and 14.
- Additional support available upon request.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Group | Experimental | * Nursing-led lactation support via secure video conferencing platforms (e.g., Zoom for Healthcare).
* Scheduled sessions at postpartum days 1, 3, 7, and 14.
* Additional support available upon request. Receives: Other: Telemedicine Group |
| In-Person Group | No intervention | * Nursing-led lactation support at the hospital bedside and during follow-up clinic visits. * Scheduled sessions at postpartum days 1, 3, 7, and 14. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding effectiveness and initiation success.
Breastfeeding effectiveness assessment wil be done by using LATCH Scoring System that incldued 5 items; Each category is scored from 0 to 2, with a maximum possible score of 10. A higher score indicates better breastfeeding effectiveness, while lower scores suggest areas needing improvement. The LATCH tool helps healthcare providers to identify and support mothers who may face challenges with breastfeeding.
Measured: after 6 months
Maternal satisfaction levels with lactation support received
Maternal satisfaction levels with lactation support received will be done using Maternal Breastfeeding Evaluation Scale (MBFES). It measures maternal attitudes, perceptions, and feelings about breastfeeding over time, making it valuable for evaluating the overall breastfeeding experience, especially in terms of emotional and practical aspects. The MBFES is typically divided into three main subscales:1. Infant Satisfaction/Growth, 2. Maternal Enjoyment/Role Attainment, and 3. Lifestyle and Physical Impact.
Mothers respond to statements on a Likert scale, typically from "strongly disagree" to "strongly agree." The total score reflects the mother's overall breastfeeding experience, with higher scores indicating a more positive experience. Lower scores may point to areas where mothers might need support or guidance, such as managing discomfort or time constraints.
Measured: At 4 weeks postpartum
Breastfeeding Self-Efficacy
The Breastfeeding Attrition Prediction Tool (BAPT) is a psychometric instrument developed to predict a mother's likelihood of discontinuing breastfeeding. The BAPT assesses various factors influencing breastfeeding behavior and attitudes, which can predict the attrition risk.The tool is composed of four main subscales:1. Positive Breastfeeding Sentiment,2. Negative Breastfeeding Sentiment, 3. Social and Professional Support , and 4. Perceived Barriers:
Responses are typically recorded on a Likert scale ranging from "strongly disagree" to "strongly agree." A higher score on the "Positive Breastfeeding Sentiment" subscale indicates a stronger commitment to breastfeeding, while higher scores on the other subscales (negative sentiment, barriers) may predict higher attrition risk. The overall score gives healthcare providers insight into wheth
Measured: at baseline (after delivery) and at 4 week postpartum
Exclusive Breastfeeding Duration
Duration and exclusivity of breastfeeding will be followed up by Weekly phone calls to mothers up to 6 months postpartum to collect breastfeeding data.
Measured: up to 6 months postpartum
Infant Growth Parameter - Weight
"Infant weight will be measured in kilograms (Kg) using a baby scale at birth, 4 weeks, and 3 months postpartum. Trained nurses will perform the measurements using standardized equipment and techniques, following World Health Organization (WHO) guidelines."
Measured: Up to 3 months postpartum
Infant Growth Parameter- Length
Length will be measured in centimeters (cm) using a measurement tape. These anthropometric measurements will be taken by trained nurses at birth, 4 weeks, and 3 months postpartum. Standardized equipment and techniques, adhering to World Health Organization (WHO) guidelines, will be employed."
Measured: Up to 3 months postpartum
Infant Growth Parameter- Head circumference
Head circumference will be measured in centimeters (cm) using a measurement tape. These anthropometric measurements will be taken by trained nurses at birth, 4 weeks, and 3 months postpartum. Standardized equipment and techniques, adhering to World Health Organization (WHO) guidelines, will be employed."
Measured: Up to 3 months postpartum
Maternal Anxiety and Stress
State-Trait Anxiety Inventory (STAI) will be used to assss the level of maternal anxiety and stress. The STAI consists of 40 self-report questions, with 20 items each for state anxiety and trait anxiety. Respondents rate how they feel "right now" (state anxiety) or how they "generally" feel (trait anxiety), typically on a 4-point Likert scale.
Measured: at baseline (after delivery) and at 4 week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Jan 2024
- Primary completion30 Nov 2024
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies 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
- Model description
- * Telemedicine Group: * Nursing-led lactation support via secure video conferencing platforms (e.g., Zoom for Healthcare). * Scheduled sessions at postpartum days 1, 3, 7, and 14. * Additional support available upon request. * In-Person Group: * Nursing-led lactation support at the hospital bedside and during follow-up clinic visits. * Scheduled sessions at postpartum days 1, 3, 7, and 14. * Additional support available upon request.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Elsharkawy, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652386
- Sponsor's protocol ID
- 530-9-2024
- Status last verified
- Mar 2025
- First submitted
- 14 Oct 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramadan OME, Alshammari AM, Alruwaili AN, Elsharkawy NB, Alhaiti A, Baraka NIM. Nurse-led telemedicine versus in-person lactation support for breastfeeding initiation in mothers of low-birth-weight infants: a non-inferiority randomized controlled trial. BMC Pregnancy Childbirth. 2025 Oct 10;25(1):1066. doi: 10.1186/s12884-025-08236-1.
PubMed 41073992
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Telemedicine Versus In-Person Lactation Support for Breastfeeding Initiation in Mothers of Low-Birth-Weight Infants: A Non-inferiority Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06652386
- Acronym / sponsor ID
- 530-9-2024
- Conditions
- Nurse's Role, Telemedicine, Lactation, Breastfeeding, Low Birth Weight Infants
- Keywords
- Nurse's Role, Telemedicine, Lactation, Breastfeeding, Low Birth Weight infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 22 Oct 2024 (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.
Breastfeeding initiation among mothers of low birth weight (LBW) infants is crucial for neonatal health but poses significant challenges. This randomized controlled trial aims to compare the effectiveness of nursing-led telemedicine lactation support versus in-person lactation support on breastfeeding initiation rates in mothers of LBW infants. The study will utilize validated tools such as the LATCH scoring system, the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), and the State-Trait Anxiety Inventory (STAI) to assess outcomes. By evaluating these two modalities, the research seeks to inform best practices for lactation support, particularly in settings where in-person care is limited.
Detailed description
Breastfeeding offers unparalleled health benefits for infants and mothers, including optimal nutrition, immune protection, and enhanced bonding. These benefits are especially critical for low-birth-weight infants, who are at increased risk for morbidity and mortality. Despite the recognized importance, mothers of low birth weight (LBW) infants often face barriers to initiating and maintaining breastfeeding due to factors such as neonatal intensive care unit (NICU) admissions, maternal stress, and lack of specialized support.
Telemedicine in Lactation Support Telemedicine has emerged as a promising avenue for delivering healthcare services, including lactation support. It offers increased accessibility and convenience, particularly for mothers who may face challenges attending in-person consultations. While telemedicine has been successfully implemented in various healthcare domains, its effectiveness compared to traditional in-person lactation support requires further investigation, particularly among mothers of LBW infants.
Nurses play a pivotal role in providing education, emotional support, and practical assistance to breastfeeding mothers.Understanding how nursing interventions can be optimized in telemedicine versus in-person settings is essential for enhancing breastfeeding initiation.
Objectives
- To compare breastfeeding initiation rates between mothers receiving telemedicine lactation support and those receiving in-person support.
- To assess changes in breastfeeding self-efficacy using the BSES-SF.
- To evaluate maternal satisfaction with the mode of lactation support received.
- To measure maternal anxiety and stress levels using the STAI.
- To monitor infant growth parameters up to 3 months postpartum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- * Telemedicine Group: * Nursing-led lactation support via secure video conferencing platforms (e.g., Zoom for Healthcare). * Scheduled sessions at postpartum days 1, 3, 7, and 14. * Additional support available upon request. * In-Person Group: * Nursing-led lactation support at the hospital bedside and during follow-up clinic visits. * Scheduled sessions at postpartum days 1, 3, 7, and 14. * Additional support available upon request.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Group | Experimental | Other: Telemedicine Group* Nursing-led lactation support via secure video conferencing platforms (e.g., Zoom for Healthcare). * Scheduled sessions at postpartum days 1, 3, 7, and 14. * Additional support available upon request. |
| In-Person Group | No intervention | –* Nursing-led lactation support at the hospital bedside and during follow-up clinic visits. * Scheduled sessions at postpartum days 1, 3, 7, and 14. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mothers aged ≥18 years.
- Mothers of infants with a birth weight <2,500 grams.
- Mothers intend to breastfeed.
- Access to a smartphone, tablet, or computer with internet capability for the telemedicine group.
Key exclusion criteria (3 listed)
- Infants with congenital anomalies affecting feeding.
- Mothers with medical conditions contraindicating breastfeeding.
- Non-English-speaking mothers (due to resource limitations).
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 |
|---|---|---|
| Telemedicine Group* Nursing-led lactation support via secure video conferencing platforms (e.g., Zoom for Healthcare). * Scheduled sessions at postpartum days 1, 3, 7, and 14. * Additional support available upon request. | Other | Telemedicine Group |
Primary outcome
Breastfeeding effectiveness and initiation success.
Time frame: after 6 months
Breastfeeding effectiveness assessment wil be done by using LATCH Scoring System that incldued 5 items; Each category is scored from 0 to 2, with a maximum possible score of 10. A higher score indicates better breastfeeding effectiveness, while lower scores suggest areas needing improvement. The LATCH tool helps healthcare providers to identify and support mothers who may face challenges with breastfeeding.
Maternal satisfaction levels with lactation support received
Time frame: At 4 weeks postpartum
Maternal satisfaction levels with lactation support received will be done using Maternal Breastfeeding Evaluation Scale (MBFES). It measures maternal attitudes, perceptions, and feelings about breastfeeding over time, making it valuable for evaluating the overall breastfeeding experience, especially in terms of emotional and practical aspects. The MBFES is typically divided into three main subscales:1. Infant Satisfaction/Growth, 2. Maternal Enjoyment/Role Attainment, and 3. Lifestyle and Physical Impact. Mothers respond to statements on a Likert scale, typically from "strongly disagree" to "strongly agree." The total score reflects the mother's overall breastfeeding experience, with higher scores indicating a more positive experience. Lower scores may point to areas where mothers might need support or guidance, such as managing discomfort or time constraints.
Breastfeeding Self-Efficacy
Time frame: at baseline (after delivery) and at 4 week postpartum
The Breastfeeding Attrition Prediction Tool (BAPT) is a psychometric instrument developed to predict a mother's likelihood of discontinuing breastfeeding. The BAPT assesses various factors influencing breastfeeding behavior and attitudes, which can predict the attrition risk.The tool is composed of four main subscales:1. Positive Breastfeeding Sentiment,2. Negative Breastfeeding Sentiment, 3. Social and Professional Support , and 4. Perceived Barriers: Responses are typically recorded on a Likert scale ranging from "strongly disagree" to "strongly agree." A higher score on the "Positive Breastfeeding Sentiment" subscale indicates a stronger commitment to breastfeeding, while higher scores on the other subscales (negative sentiment, barriers) may predict higher attrition risk. The overall score gives healthcare providers insight into wheth
Exclusive Breastfeeding Duration
Time frame: up to 6 months postpartum
Duration and exclusivity of breastfeeding will be followed up by Weekly phone calls to mothers up to 6 months postpartum to collect breastfeeding data.
Infant Growth Parameter - Weight
Time frame: Up to 3 months postpartum
"Infant weight will be measured in kilograms (Kg) using a baby scale at birth, 4 weeks, and 3 months postpartum. Trained nurses will perform the measurements using standardized equipment and techniques, following World Health Organization (WHO) guidelines."
Infant Growth Parameter- Length
Time frame: Up to 3 months postpartum
Length will be measured in centimeters (cm) using a measurement tape. These anthropometric measurements will be taken by trained nurses at birth, 4 weeks, and 3 months postpartum. Standardized equipment and techniques, adhering to World Health Organization (WHO) guidelines, will be employed."
Infant Growth Parameter- Head circumference
Time frame: Up to 3 months postpartum
Head circumference will be measured in centimeters (cm) using a measurement tape. These anthropometric measurements will be taken by trained nurses at birth, 4 weeks, and 3 months postpartum. Standardized equipment and techniques, adhering to World Health Organization (WHO) guidelines, will be employed."
Maternal Anxiety and Stress
Time frame: at baseline (after delivery) and at 4 week postpartum
State-Trait Anxiety Inventory (STAI) will be used to assss the level of maternal anxiety and stress. The STAI consists of 40 self-report questions, with 20 items each for state anxiety and trait anxiety. Respondents rate how they feel "right now" (state anxiety) or how they "generally" feel (trait anxiety), typically on a 4-point Likert scale.
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 26 Mar 2025.
- Derived from this study: PubMed 41073992Ramadan OME, Alshammari AM, Alruwaili AN, Elsharkawy NB, Alhaiti A, Baraka NIM. Nurse-led telemedicine versus in-person lactation support for breastfeeding initiation in mothers of low-birth-weight infants: a non-inferiority randomized controlled trial. BMC Pregnancy Childbirth. 2025 Oct 10;25(1):1066. doi: 10.1186/s12884-025-08236-1.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Group in people with Nurse's Role and Telemedicine, run by Jouf University at 1 site in Egypt.
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 4 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 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Breastfeeding effectiveness and initiation success. (time frame: after 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652386, which also lists 1 linked publication.
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 26 Mar 2025.