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

Trial Summary

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 data supports the effectiveness of the treatment wearable wireless breast pumps for mothers of premature infants?

Research shows that wearable breast pumps help mothers, like physician mothers, take shorter breaks and successfully provide breast milk for their intended duration. This suggests that wearable pumps can be effective in helping mothers of premature infants maintain their milk supply. ^{1 2 3 4 5}

What safety data exists for wearable wireless breast pumps?

Some safety concerns with breast pumps, including wearable wireless ones, have been reported, such as pain, soreness, breast tissue damage, and infections. These issues highlight the importance of improving pump design to reduce risks. ^{1 6 7 8 9}

How do wearable wireless breast pumps differ from traditional breast pumps for mothers of premature infants?

Wearable wireless breast pumps are unique because they allow mothers to pump breast milk hands-free and more discreetly, which can be especially beneficial for mothers returning to work. This convenience can lead to shorter lactation breaks and help mothers meet their breastfeeding goals more effectively compared to traditional electric breast pumps. ^{1 2 3 5 10}

What is the purpose of this trial?

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

Research Team

Alan Groves

Principal Investigator

University of Texas at Austin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Impact of Wearable Breast Pumps on Physicians' Breastfeeding Experience and Success. [2022]

2. United States 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. [2018]

3. India 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The utility of a bilateral breast pumping system for mothers of premature infants. [2015]

5. Australia pubmed.ncbi.nlm.nih.gov

Manual expression and electric breast pumping in the first 48 h after delivery. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Breast pump adverse events: reports to the food and drug administration. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Pay at the pump?: Problems with electric breast pumps. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Maternal and breast pump factors associated with breast pump problems and injuries. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Breast pump access in the inner city: a hospital-based initiative to provide breast pumps for low-income women. [2018]