Clinical trial NCT06652386: Nurse-Led Telemedicine Versus In-Person Lactation Support for Breastfeeding Initiation of Low-Birth-Weight Infants
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Telemedicine
Lactation
Breastfeeding
Low Birth Weight Infants
Keywords: Nurse's Role
Telemedicine
Lactation
Breastfeeding
Low Birth Weight infants
Lead sponsor: Jouf University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Breastfeeding effectiveness and initiation success.
timeFrame: after 6 months
measure: Maternal satisfaction levels with lactation support received
timeFrame: At 4 weeks postpartum
measure: Breastfeeding Self-Efficacy
timeFrame: at baseline (after delivery) and at 4 week postpartum
measure: Exclusive Breastfeeding Duration
timeFrame: up to 6 months postpartum
measure: Infant Growth Parameter - Weight
timeFrame: Up to 3 months postpartum
measure: Infant Growth Parameter- Length
timeFrame: Up to 3 months postpartum
measure: Infant Growth Parameter- Head circumference
timeFrame: Up to 3 months postpartum
measure: Maternal Anxiety and Stress
timeFrame: at baseline (after delivery) and at 4 week postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Gharbia Governorate
Study officials:
References: