30 Participants Needed

Wearable Wireless Breast Pumps for Mothers of Premature Infants

(MTMM Trial)

EO
Overseen ByErica Ortiz
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: University of Texas at Austin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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 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.12345

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.36789

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.367810

Who Is on the Research Team?

AG

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?
2Treatment groups
Experimental Treatment
Group I: Wearable wireless pump provided in week twoExperimental Treatment1 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 oneExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

The Impact of Wearable Breast Pumps on Physicians' Breastfeeding Experience and Success. [2022]
A comparison of the efficiency, efficacy, comfort, and convenience of two hospital-grade electric breast pumps for mothers of very low birthweight infants. [2018]
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]
The utility of a bilateral breast pumping system for mothers of premature infants. [2015]
Manual expression and electric breast pumping in the first 48 h after delivery. [2016]
Breast pump adverse events: reports to the food and drug administration. [2018]
Pay at the pump?: Problems with electric breast pumps. [2022]
Maternal and breast pump factors associated with breast pump problems and injuries. [2015]
Measuring Mothers' Viewpoints of Breast Pump Usage. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Breast pump access in the inner city: a hospital-based initiative to provide breast pumps for low-income women. [2018]
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