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

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.

Study Overview

• Status: Completed
• Conditions: Telemedicine; Nurse's Role; Lactation; Breastfeeding; Low Birth Weight Infants
• Intervention / Treatment: Other: Telemedicine Group

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 2014
      • Tanta University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jouf University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Lactation; Breastfeeding; Nurse's Role; Low Birth Weight infants
• Additional Relevant MeSH Terms: Birth Weight; Body Weight
• Other Study ID Numbers: 530-9-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No