AI-Based Oxytocin-Stimulated Smart Lactation Support Vest: Development of a Thermo-Massage and Vibration Wearable Vest Design to Support Milk Flow and Prevent Milk Duct Obstruction During Lactation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- Daily Expressed Breast Milk Volume (mL/day)
研究概览
简要总结
AI-Based Oxytocin-Stimulated Smart Lactation Support Vest: Development of a Thermo-Massage and Vibration Wearable Vest Design to Support Milk Flow and Prevent Milk Duct Obstruction During Lactation
详细描述
This randomized controlled trial is the second phase of a three-stage project aimed at developing and clinically evaluating an artificial intelligence (AI)-based oxytocin-stimulated smart lactation support vest with thermo-massage and vibration technologies. The overall project includes prototype development, randomized controlled clinical evaluation, and a qualitative assessment of mothers' experiences with the device.
The randomized controlled trial will evaluate the effectiveness of the AI-based oxytocin-stimulated smart lactation support vest in mothers who have delivered by cesarean section at 32-37 weeks of gestation and whose newborns are hospitalized in the Neonatal Intensive Care Unit (NICU). Because separation of the mother and newborn and the inability to directly breastfeed may interfere with the initiation and maintenance of lactation in this population, the intervention is designed to support milk production and milk flow during the early postpartum period.
The smart lactation support vest is a wearable system incorporating controlled thermo-massage and vibration stimulation. The vest includes heating elements, vibration units, massage and heating components, temperature and bioelectrical impedance sensors, an embedded electronic control system, a rechargeable battery, a control panel, and a mobile application. The system is designed to provide synchronized stimulation to the breast and upper back/scapular region. The breast-area components provide controlled thermal and vibration stimulation, while the back-area massage and heating components are intended to promote relaxation and support the physiological milk ejection reflex. The intervention is designed to support endogenous oxytocin release and facilitate milk flow without administration of exogenous oxytocin.
The AI-based decision-support module integrated into the mobile application will evaluate device-use parameters and user-related information and will provide individualized recommendations regarding the duration and intensity of thermo-massage and vibration stimulation. The system will use information obtained from temperature and bioelectrical impedance sensors together with milk volume, breast fullness, stimulation parameters, duration of use, session frequency, and user feedback. The AI module is intended to function as a supportive decision-support system and will not provide medical diagnosis or treatment decisions. If predefined warning indicators suggesting increased breast temperature and fullness are detected, the system will provide an alert advising the mother to seek evaluation by a healthcare professional.
Eligible participants will be randomly allocated in a 1:1 ratio to either the smart lactation support vest group or the control group. Stratified randomization according to gestational age (32-34 weeks and 35-37 weeks) will be used to promote balance between groups with respect to gestational age.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For Mothers:
- •Aged 18 years or older;
- •Primiparous;
- •Delivered by cesarean section;
- •Singleton pregnancy;
- •Delivered at 32-37 weeks of gestation;
- •Newborn admitted to the Neonatal Intensive Care Unit (NICU);
- •No medical condition that would prevent breast milk expression or use of the smart lactation support vest;
- •Owns or has access to a smartphone;
- •Willing to participate voluntarily and able to provide written informed consent;
- •Able to read, understand, and communicate in Turkish.
- •For Newborns:
- •Born at 32-37 weeks of gestation;
- •No condition that would prevent the intake of breast milk.
排除标准
- •For Mothers:
- •Body mass index (BMI) >30 kg/m²;
- •History of a psychiatric diagnosis or currently receiving psychiatric treatment (e.g., depression, schizophrenia, obsessive-compulsive disorder);
- •Any medical condition that may interfere with breast milk expression (e.g., mastitis);
- •Stillbirth;
- •History of thyroid dysfunction;
- •Any physical condition or disability that prevents wearing the smart lactation support vest;
- •Previous breast surgery (e.g., breast implant surgery, mastectomy);
- •Insufficient Turkish language proficiency preventing the participant from understanding and completing the study instruments.
- •For Newborns:
- •Cleft palate or cleft lip;
- •Congenital anomaly;
- •Requirement for mechanical ventilation.
研究组 & 干预措施
Arm 1 - Intervention
Participants assigned to the intervention group will use the AI-based oxytocin-stimulated smart lactation support vest for 10 days, three times daily, in addition to standard lactation care and counseling. Each session will consist of 5 minutes of heating, 15 minutes of heating combined with massage, and 10 minutes of heating combined with massage and vibration. The wearable system is designed to provide controlled thermo-massage and vibration stimulation to support milk flow and lactation during the early postpartum period.
干预措施: AI-Based Oxytocin-Stimulated Smart Lactation Support Vest (Device)
Arm 2 - Control
Participants assigned to the control group will receive standard lactation care and counseling according to the hospital protocol. Standard care will include routine lactation counseling, guidance regarding breastfeeding and milk expression, breast care, storage of expressed breast milk, daily reminders to express milk, and lactation support when clinically indicated.
干预措施: AI-Based Oxytocin-Stimulated Smart Lactation Support Vest (Device)
Arm 2 - Control
Participants assigned to the control group will receive standard lactation care and counseling according to the hospital protocol. Standard care will include routine lactation counseling, guidance regarding breastfeeding and milk expression, breast care, storage of expressed breast milk, daily reminders to express milk, and lactation support when clinically indicated.
干预措施: Standard Lactation Care and Counseling (Behavioral)
结局指标
主要结局
Daily Expressed Breast Milk Volume (mL/day)
时间窗: Baseline (Day 0) through Day 10 postpartum
The amount of breast milk expressed by the mother per day, measured in milliliters (mL/day) during the 10-day follow-up period.
次要结局
- Maternal Serum Oxytocin Level (pg/mL)(Baseline, Day 5, and Day 10)
- Maternal Serum Prolactin Level (ng/mL)(Baseline, Day 5, and Day 10)
- Maternal Serum Cortisol Level (µg/dL)(Baseline, Day 5, and Day 10)
- Breast Fullness(Day 1 through Day 10)
- Lactation Onset Symptoms(Day 1 through Day 10)
- Daily Newborn Expressed Breast Milk Intake (mL/day)(Day 1 through Day 10)
- Newborn Blood Glucose Level (mg/dL)(Day 1 through Day 10)
- Newborn Bilirubin Level (mg/dL)(Day 1 through Day 10)
- Maternal Well-Being(Baseline and Day 10)
- Postpartum-Specific Anxiety(Baseline and Day 10)
研究者
Seyhan Çankaya
Assoc.Prof.
Selcuk University