Wearable Wireless Breast Pumps for Mothers of Premature Infants

(MTMM Trial)

Overseen By Erica Ortiz

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Current use of wearable pump

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether wearable wireless breast pumps help mothers of premature infants pump more milk and do so more frequently. The study compares two groups: one receives the pump in the first week, while the other receives it in the second week, with support from a lactation specialist for both. Mothers who gave birth at 29 weeks or earlier and continue pumping four weeks after birth may qualify for this trial, provided they are not already using a wearable pump. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support for mothers of premature infants.

Do I need to stop taking 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 wireless breast pump is safe for mothers of premature infants?

Research shows that wearable wireless breast pumps are generally easy for users to tolerate. Designed for comfort, these pumps fit gently around the breast and send milk data wirelessly. Studies have not reported any major problems linked to their use.

Since this trial involves a wearable breast pump, it's important to note that many mothers, including doctors, have successfully used these pumps to express milk during shorter breaks. This suggests that the pumps are easy to use and safe for most people.

While specific safety data from this trial is not yet available, the absence of significant negative reports in other studies is reassuring. Consulting a healthcare provider is always advisable for any personal concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about wearable wireless breast pumps for mothers of premature infants because these pumps offer a new level of convenience and mobility compared to traditional breast pumps, which often require being tethered to an electrical outlet. With this technology, mothers can pump discreetly and comfortably while on the go, potentially improving milk production and reducing stress. Additionally, the integration of lactation specialist support aims to enhance maternal confidence and breastfeeding success rates, which is crucial for the health of premature infants. By combining modern technology with personalized care, this approach could revolutionize breastfeeding practices for mothers of preemies.

What evidence suggests that wearable wireless breast pumps are effective for mothers of premature infants?

This trial will evaluate the effectiveness of wearable wireless breast pumps for mothers of premature infants. Studies have shown that these pumps can make pumping more comfortable and efficient. In a recent trial, the pumps improved the breastfeeding experience for mothers, particularly those with busy jobs, by reducing the time needed for pumping breaks. This suggests that the pumps could help mothers of premature babies pump more milk, more often. Although data specifically on mothers of premature babies is limited, the comfort and convenience of these pumps could help increase milk supply. Overall, wearable wireless pumps show promise in supporting mothers in their breastfeeding journey. ^{1 2 4 6 7}

Who Is on the Research Team?

Alan Groves

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for mothers with premature infants who want to participate in a study evaluating the effectiveness of wearable, wireless breast pumps. Specific eligibility criteria are not provided.

Inclusion Criteria

Mother of infant born at 29+6 weeks or below

Mother still pumping at 4 weeks since birth

Exclusion Criteria

Current use of mother's own wearable pump

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a wearable, wireless breast pump in addition to their usual hospital grade pump

2 weeks

Weekly visits with lactation specialist support

Follow-up

Participants are monitored for milk volume and frequency of pumping sessions

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Wearable wireless breast pump

Trial Overview The study is testing whether using wearable, wireless breast pumps affects how often and how much milk mothers can express compared to traditional methods.

How Is the Trial Designed?

Group I: Wearable wireless pump provided in week two Experimental Treatment 1 Intervention

Standard of care in week one, provision of a wearable, wireless pump in week two with support from a lactation specialist.

Group II: Wearable wireless pump provided in week one Experimental Treatment 1 Intervention

Provision of a wearable, wireless pump in week one with support from a lactation specialist, standard of care in week two.

Wearable wireless breast pump is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Wearable breast pump for:

• Milk expression for mothers of premature infants

Approved in European Union as Wearable breast pump for:

• Milk expression for mothers of premature infants
• General lactation support

Approved in Canada as Wearable breast pump for:

• Milk expression for mothers of premature infants

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

In a clinical trial involving 100 mothers of very low birthweight infants, the Symphony breast pump (SBP) was found to be significantly more comfortable, efficient, and effective compared to the Classic breast pump (CBP), despite similar overall milk output.

The study indicated that the single-phase suction pattern of the SBP led to quicker milk ejection compared to the multiphase pattern, suggesting that mothers may adapt better to the single-phase method, enhancing their pumping experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the efficiency, efficacy, comfort, and convenience of two hospital-grade electric breast pumps for mothers of very low birthweight infants. Meier, PP., Engstrom, JL., Hurst, NM., et al.[2018]

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]

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]

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]

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]

In a study involving 11 women, manual breast expression yielded a higher volume of milk (median 2 mL) compared to electric pumping (median 0.6 mL) within the first 48 hours after birth, indicating that manual expression may be more effective for maximizing milk volume.

Electric breast pumping was associated with significantly less pain, with 90% of women reporting no pain compared to only 36% with manual expression, suggesting it may be a better option for mothers who experience discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual expression and electric breast pumping in the first 48 h after delivery. Ohyama, M., Watabe, H., Hayasaka, Y.[2016]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06723067?utm_source=trialradar

A Randomized Controlled Trial of Impact of Wearable, ... A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump. Detailed ...

2. withpower.com withpower.com/trial/wearable-wireless-breast-pumps-for-mothers-of-premature-infants-d86ec

Wearable Wireless Breast Pumps for Mothers of Premature ... In a clinical trial involving 100 mothers of very low birthweight infants, the Symphony breast pump (SBP) was found to be significantly more comfortable, ...

3. trialx.com trialx.com/clinical-trials/listings/310751/a-randomized-controlled-trial-of-impact-of-wearable-wireless-breast-pumps-on-frequency-and-efficacy-of-milk-expression-in-mothers-of-premature-infants/

A Randomized Controlled Trial of Impact of Wearable, ... A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump.

4. trial.medpath.com trial.medpath.com/clinical-trial/6383836e2c55da33/nct06723067-impact-wearable-breast-pumps-milk-expression

A Randomized Controlled Trial of Impact of Wearable ... A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump.

5. researchgate.net researchgate.net/publication/359148092_The_Impact_of_Wearable_Breast_Pumps_on_Physicians'_Breastfeeding_Experience_and_Success

The Impact of Wearable Breast Pumps on Physicians ... A recent study showed using wearable pumps improved the lactation experience for individuals working in the health sector, resulting in shorter lactation breaks ...

6. news.northwestern.edu news.northwestern.edu/stories/2025/05/got-data-breastfeeding-device-measures-babies-milk-intake-in-real-time

Got data? Breastfeeding device measures babies' milk intake ... The unobtrusive device softly and comfortably wraps around the breast of a nursing parent during breastfeeding and wirelessly transmits data to ...

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

Breast Pumps - Medical Clinical Policy Bulletins For premature infants, breast milk helps prevent infections, speeds recovery from respiratory distress syndrome, increases weight gain, protects against ...