AI-Based Oxytocin-Stimulated Smart Lactation Support Vest

What Was Tested

The trial (not phased) is built around Oxytocin.

It had two arms (groups): Arm 1 - Intervention (experimental) and Arm 2 - Control (active comparator).

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.

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.

The registry classes the interventions as behavioral and device.

More on the Plan

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.

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.

Who Took Part

Enrollment: 76 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged 18 years or older;. Delivered by cesarean section;. Delivered at 32-37 weeks of gestation;. Newborn admitted to the Neonatal Intensive Care Unit (NICU);. Owns or has access to a smartphone;.

The full record lists 12 inclusion and 11 exclusion criteria; among the exclusions: 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);.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-12-01 with completion listed for 2027-12-01.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Daily Expressed Breast Milk Volume (mL/day) (time frame: Baseline (Day 0) through Day 10 postpartum).

It also tracked 10 secondary outcomes, for example Maternal Serum Oxytocin Level (pg/mL), Maternal Serum Prolactin Level (ng/mL), Maternal Serum Cortisol Level (µg/dL), Breast Fullness, Lactation Onset Symptoms and Daily Newborn Expressed Breast Milk Intake (mL/day).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 76 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.