Nurse-Led Telemedicine Versus In-Person Lactation Support for Breastfeeding Initiation in Mothers of Low-Birth-Weight Infants: A Non-inferiority Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Breastfeeding effectiveness and initiation success.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Infants with congenital anomalies affecting feeding.
- •Mothers with medical conditions contraindicating breastfeeding.
- •Non-English-speaking mothers (due to resource limitations).
结局指标
主要结局
Breastfeeding effectiveness and initiation success.
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Nadia Elsharkawy
Associtae Professor
Jouf University