Nurse-Led Telemedicine Versus In-Person Lactation Support for Breastfeeding Initiation of Low-Birth-Weight Infants

NCT06652386 | Completed

• 1 other identifier: 530-9-2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Nurse's Role; Telemedicine; Lactation; Breastfeeding; Low Birth Weight Infants

Keywords

Nurse's Role; Telemedicine; Lactation; Breastfeeding; Low Birth Weight infants

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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

  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.

  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."

  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."

  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."

  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.

  at baseline (after delivery) and at 4 week postpartum

Study Arms (2)

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.

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.

Interventions

Telemedicine Group OTHER

* 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.

Telemedicine Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Infants with congenital anomalies affecting feeding.
• Mothers with medical conditions contraindicating breastfeeding.
• Non-English-speaking mothers (due to resource limitations).

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

Tanta University Hospital

Tanta, Gharbia Governorate, 2014, Egypt

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to either the telemedicine or in-person support group using a computer-generated randomization sequence with block sizes of varying lengths to ensure allocation concealment and they are unaware of which group they have been assigned to as well as the outcome assessor is unaware
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associtae Professor

Model Details: * 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.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 22, 2024
• Study Start: January 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: February 24, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

EG (1)