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

NCT ID: NCT06652386

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-02-24

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Telemedicine Group

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jouf University

OTHER

Sponsor Role: lead

Responsible Party

Nadia Elsharkawy

Associtae Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospital

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

530-9-2024

Identifier Type: -

Identifier Source: org_study_id