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NCT07765992
AI-Based Oxytocin-Stimulated Smart Lactation Support Vest
Conditions: Lactation, Lactation Disorder - Postpartum Condition or Complication, Breast Feeding
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 76
Sponsor: Selcuk University
Summary
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
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Source: ClinicalTrials.gov (NCT07765992). StuddyBuddy aggregates publicly available trial information.