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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07765992). StuddyBuddy aggregates publicly available trial information.