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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 20-22 days
Awards & highlights

Study Summary

This trial is testing whether a new, discreet, wearable breast pump can help Black mothers of infants in the neonatal intensive care unit (NICU) produce more breast milk.

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.Check my eligibility
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.See study design
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
Select...
I am older than 18 years.
Select...
I have a mobile phone and can download apps.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants acceptance of the intervention
Secondary outcome measures
Expressed milk volume
Expression frequency
Infant consumption
+2 more

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.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,656 Total Patients Enrolled
Leslie ParkerPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
301 Total Patients Enrolled

Media Library

Hands free wearable breast pump (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05147987 — N/A
Low Milk Supply Research Study Groups: Intervention Group, Standard care group
Low Milk Supply Clinical Trial 2023: Hands free wearable breast pump Highlights & Side Effects. Trial Name: NCT05147987 — N/A
Hands free wearable breast pump (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05147987 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Improving Lactation Success in Black Mothers of Critically Ill Infants
2022. "Improving Lactation Success in Black Mothers of Critically Ill Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05147987.
~15 spots leftby Oct 2025
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