Wearable Breast Pump for Low Milk Supply

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Illicit drug use, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a hands-free, wearable breast pump with an app can help Black mothers of infants in the neonatal intensive care unit (NICU) produce more breast milk. Researchers seek to understand whether this pump increases the frequency and volume of milk production compared to a standard pump without an app. The trial targets Black mothers who plan to provide breast milk for at least three weeks and have infants in the NICU who cannot be fed by bottle or breast for over 21 days. Participants must have access to a smartphone to use the related app. Results from this trial could pave the way for a larger study in the future. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance breastfeeding support for Black mothers with infants in the NICU.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this wearable breast pump is safe for increasing lactation success?

Research has shown that hands-free, wearable breast pumps are generally safe to use. Studies have found these pumps to be comfortable and easy to operate, though some users might experience sore nipples. This issue is the most commonly reported and can occur with any type of pump, not just wearable ones.

While wearable pumps might not always collect as much milk as traditional pumps, they are designed to keep the milk separate from the pump parts, reducing contamination risk.

Overall, these pumps are well-received and offer the convenience of discreet, hands-free use, which can be helpful for mothers who need to pump frequently. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wearable breast pump for low milk supply because it offers a hands-free and discreet pumping experience. Unlike traditional mechanical breast pumps that can be cumbersome and require manual operation, this wearable pump integrates with an app, providing users with the convenience of monitoring and adjusting settings via their smartphones. This new approach not only aims to enhance comfort and ease of use for nursing mothers but also hopes to improve milk supply management by offering data-driven insights into their pumping habits.

What evidence suggests that this wearable breast pump is effective for increasing breast milk production?

Research shows that wearable breast pumps can ease breastfeeding. In this trial, participants in the intervention group will receive a discreet, hands-free, wearable breast pump with an associated app. A recent study found that these pumps help mothers breastfeed longer and increase milk supply. Many mothers reported greater satisfaction with wearable pumps compared to traditional ones. However, some evidence suggests these pumps might not empty the breast as effectively due to less suction power. Despite this, they offer convenience and reduce the need for long breaks, especially at work. Overall, early findings suggest wearable pumps could improve breastfeeding outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Leslie Parker

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am older than 18 years.

I can attend a 30-minute education session before leaving the hospital.

I have a mobile phone and can download apps.

Exclusion Criteria

The baby is not expected to live more than 7 days after being born.

You have a history of using illegal drugs.

I have had breast surgery to change size.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are provided with either a discreet, hands-free, wearable breast pump with an associated App or a standard mechanical breast pump without an App

21 days

Regular monitoring visits

Follow-up

Participants are monitored for lactation duration, expressed milk volume, and infant consumption

100 days

What Are the Treatments Tested in This Trial?

Interventions

• Hands free wearable breast pump

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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

Group II: Standard care group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

A study comparing four manual breast pumps (MBPs) found no significant differences in milk volume, nutritional composition, or breast emptying, indicating that all tested pumps are equally effective for milk expression.

Mothers preferred the squeeze-handle pumps over cylindrical ones for comfort and ease of use, highlighting the importance of user experience alongside effectiveness and cost when selecting pumps for use in special care nurseries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of four manual breast pumps for mothers after preterm delivery in a developing country. Bernabe-Garcia, M., Lopez-Alarcon, M., Villegas-Silva, R., et al.[2019]

Power pumping (PP) resulted in significantly higher milk volume expressed per session compared to routine pumping (RP), with 50 mL vs. 27 mL on the 7th day, indicating that PP may enhance milk production in the short term.

Despite the increased milk volume from power pumping, there was no significant difference in exclusive breastfeeding rates at discharge between the two groups, with 61.1% in PP and 50% in RP (p=0.477), suggesting that higher milk output does not necessarily translate to improved breastfeeding outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two Pumping Strategies to Improve Exclusive Breastfeeding at Discharge in Mothers of VLBW Infants with Low Milk Output - A Pilot Randomized Controlled Trial. Kalathingal, T., Manerkar, S., Mondkar, J., et al.[2023]

Using a bilateral breast pumping system did not increase the total volume of milk produced by mothers of premature infants compared to a single pump, but it significantly reduced the time spent pumping (7.6 hours/week vs. 11.1 hours/week).

The study involved 32 mothers who pumped at least four times a day over a period of four to six weeks, suggesting that while both pumping methods yield similar milk production, the bilateral pump is more time-efficient and should be recommended by health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of a bilateral breast pumping system for mothers of premature infants. Groh-Wargo, S., Toth, A., Mahoney, K., et al.[2015]

At Boston Medical Center, a program was established to ensure that all breastfeeding mothers, especially those with infants in the neonatal intensive care unit, receive access to effective electric breast pumps, regardless of their insurance status or financial situation.

This initiative addresses significant barriers faced by uninsured or low-income women in accessing breast pumps, which are crucial for managing breastfeeding challenges and supporting maternal employment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast pump access in the inner city: a hospital-based initiative to provide breast pumps for low-income women. Chamberlain, LB., McMahon, M., Philipp, BL., et al.[2018]

Breast pumps, while marketed for convenience and efficiency, can lead to significant issues for women, including electrical malfunctions, suction problems, fluid leaks, injuries, and infections.

The FDA regulates breast pumps as medical devices and collects data on adverse events, highlighting the need for improved design and safety in future breast pump technology to better protect women's health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pay at the pump?: Problems with electric breast pumps. Leiter, V., Agiliga, A., Kennedy, E., et al.[2022]

A study identified 41 adverse event reports related to breast pumps from 1992 to 2003, highlighting issues such as pain, soreness, and breast tissue damage, particularly with electric pumps.

The findings suggest that adverse events, including contamination of breast milk and infections from manual pumps, are likely underreported, emphasizing the need for better reporting to enhance breast pump safety and design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast pump adverse events: reports to the food and drug administration. Brown, SL., Bright, RA., Dwyer, DE., et al.[2018]

Breastfeeding has significant short- and long-term health benefits for children, but when direct breastfeeding isn't possible, expressed or pumped milk is an important alternative.

This systematic review of 18 randomized control trials highlights that mothers often face challenges and have negative perceptions about breast pumps, suggesting that improving the comfort and usability of these devices could enhance the likelihood of infants receiving human milk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Mothers' Viewpoints of Breast Pump Usage. Becker, GE.[2021]

About 62% of mothers reported problems with breast pumps, and 15% reported injuries, with the most common issues being insufficient milk extraction and sore nipples.

Using battery-operated pumps and planning to breastfeed for less than 12 months increased the risk of problems and injuries, while learning to use the pump from a friend reduced these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal and breast pump factors associated with breast pump problems and injuries. Qi, Y., Zhang, Y., Fein, S., et al.[2015]

A survey of 542 female physicians showed that those using wireless, wearable breast pumps experienced significantly shorter lactation breaks compared to those using traditional pumps, indicating improved convenience in the workplace.

Physician mothers using wearable pumps were also more likely to meet their breastfeeding goals, successfully providing breast milk for the intended duration, highlighting the potential of these devices to support lactation success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Wearable Breast Pumps on Physicians' Breastfeeding Experience and Success. Colbenson, GA., Hoff, OC., Olson, EM., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2667268523000141

an evaluation of efficacy and comfort of hands-free, in-bra ... A recent study showed using wearable pumps improved the lactation experience for individuals working in the health sector, resulting in shorter lactation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8207928/

A GME Wearable Breast Pump Program: An Innovative ... Outcomes to Date · Increase the length of time a mother can more easily provide breast milk to their infant · Increase milk supply · Increase satisfaction, ...

3. mdpi.com mdpi.com/2504-3900/93/1/12

A Comparison of the Efficacy and Comfort of Traditional ... Most mothers found Freestyle with IBCPS to be more comfortable compared with their home pumps (IBCPS: 2.1 ± 0.9; Traditional: 2.8 ± 0.8, p < ...

4. withpower.com withpower.com/trial/phase-critical-illness-11-2021-23951

Wearable Breast Pump for Low Milk Supply A survey of 542 female physicians showed that those using wireless, wearable breast pumps experienced significantly shorter lactation breaks compared to those ...

5. centracare.com centracare.com/articles-stories/wearable-breast-pumps-pros-cons/

Wearable Breast Pumps: A Lactation Consultant's Pros and ... Wearable pumps tend to have lower suction capabilities. For some, this may mean the pump won't adequately empty the breast and your milk supply ...

6. es.aetna.com es.aetna.com/cpb/medical/data/400_499/0421.html

Breast Pumps - Medical Clinical Policy Bulletins The most commonly reported problem was that the pump did not extract enough milk and the most commonly reported injury was sore nipples. Using a battery- ...

7. kior.com kior.com/products/kior-wearable-hands-free-breast-pump?srsltid=AfmBOoo1eoBgFjYTZKQ0pJqoxq1zVjifQypnhuX21Gz80KDnk88D9xaW

KIOR Wearable Hands Free Breast Pump The anti-reverse flow design prevents breast milk from being contaminated as it uses a closed system, which keeps milk completely separate from the pump pieces.