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Wearable vest aims to boost milk flow and prevent blocked ducts

NCT ID NCT07765992

Symptom relief Sponsor: Selcuk University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests a wearable vest that uses heat, massage, and vibration to stimulate milk flow in mothers who have had a cesarean delivery and whose babies are in the NICU. Participants use the vest three times daily for 10 days, alongside standard lactation care. The study measures daily milk volume and hormone levels to see if the device can support breastfeeding and prevent milk duct obstruction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-based smart lactation support vest that provides heat, massage, and vibration stimulation
What this could lead to
If effective, this wearable vest could offer a drug-free way to boost milk production and reduce the risk of blocked milk ducts in mothers of premature babies.
What could go wrong
This is an early-stage device trial with a small number of participants, so results may not apply to all mothers. The device's comfort and safety during daily use are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Breast Feeding puerperal disorder lactocele prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast feeding Lactation Lactation disorder - postpartum condition or complication

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.