What side effects are associated with this type of intervention?

Common treatments for low milk supply include the use of breast pumps, particularly hands-free, wearable models that increase pumping frequency and track milk production. Known side effects of using breast pumps can include nipple pain, breast tissue damage, and potential infections if the equipment is not properly sanitized. Additionally, some users may experience discomfort or inconvenience from wearing the device for extended periods. However, these side effects are generally mild and can be managed with proper usage and hygiene practices.

What prior FDA approvals exist?

There are no specific FDA-approved drugs or treatments mentioned in the provided context for the treatment of low milk supply. The context discusses a pilot study evaluating the feasibility and potential benefits of a discreet, hands-free, wearable breast pump with an associated app to increase pumping frequency and breast milk production in Black mothers of critically ill infants. This study aims to address the unique challenges faced by these mothers, but it does not mention any prior FDA approvals for similar treatments.

What other types of research exist?

Promising alternatives for low milk supply patients in 2024 may include: 1) Advanced electric breast pumps with enhanced comfort and efficiency features, 2) Lactation support apps that offer personalized guidance and tracking without the need for a specific pump, 3) Wearable sensors that monitor milk production and provide real-time feedback, 4) Nutritional supplements and medications specifically designed to enhance milk production, and 5) Tele-lactation consultations providing remote support and advice from lactation experts.

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Device

Wearable Breast Pump for Low Milk Supply

N/A

Waitlist Available

Led By Leslie Parker

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

> 18 years of age

Access to a mobile phone and able to download app.

Must not have

Breast reduction or augmentation

Positive HIV status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 20-22 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help Black mothers of critically ill infants in the NICU by providing a wearable breast pump that can be used hands-free. The pump comes with an app that tracks how often they pump and how much milk they produce. This could make it easier for these mothers to provide more breast milk for their babies.

Who is the study for?

This trial is for Black mothers over 18 with critically ill infants in the NICU who intend to pump breast milk and can attend a training session. They must have a mobile phone, be English-speaking, and not expect their infant to bottle/breastfeed within 21 days. Exclusions include drug use, breast surgery history, HIV positivity, pacemaker presence or if the infant's life expectancy is under 7 days.

What is being tested?

The study tests whether a discreet hands-free wearable breast pump increases lactation success compared to standard pumps without an app. It aims to improve pumping frequency and milk production among Black mothers of NICU infants by using technology that tracks these metrics.

What are the potential side effects?

While there are no direct medical side effects from using a breast pump, potential issues may include discomfort during use, nipple irritation or soreness, and possible stress related to adapting to new technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have a mobile phone and can download apps.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had breast surgery to change size.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 20-22 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 20-22 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 20-22 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants acceptance of the intervention

Secondary study objectives

Expressed milk volume

Expression frequency

Infant consumption

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

Will be provided a discreet, hands-free, wearable breast pump with an associated App

Group II: Standard care groupActive Control1 Intervention

Will be provided a standard mechanical breast pump with no associated App.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for low milk supply include frequent breast pumping, use of breast pumps that mimic the baby's sucking pattern, and tracking milk production. The discreet, hands-free, wearable breast pump with an associated app increases pumping frequency and provides real-time data on milk production. This matters for patients with low milk supply because frequent stimulation of the breasts can enhance milk production by promoting the release of prolactin and oxytocin, hormones essential for milk synthesis and ejection. Additionally, tracking milk production helps in identifying patterns and making necessary adjustments to improve lactation success.