Hands-free pump aims to boost lactation for black mothers in the NICU
NCT ID NCT05147987
First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This pilot study tested whether a discreet, hands-free wearable breast pump could help Black mothers of critically ill infants in the NICU pump more often and produce more milk. Forty mothers were randomly assigned to use either the wearable pump with a tracking app or a standard pump. The goal was to see if the wearable pump is feasible and shows promise for a larger future study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hands-free wearable breast pump
- What this could lead to
- If it works, this could point toward a practical way to help Black mothers in the NICU pump more often and produce more breast milk.
- What could go wrong
- This is a very small pilot study with only 40 participants, so results may not apply widely. The device may not significantly improve milk production or pumping frequency.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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32 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Mothers self-identified as Black * \> 18 years of age * English speaking * Stated intent to provide breast milk to her infant * Rate their level of commitment to pumping breast milk for their infant for at least 3 weeks as 3 or greater or a 1-5 point Likert scale * State they are available for an approximately 30 minute education session prior to hospital discharge * Infant not expected to be stable enough to bottle/breastfeed for \> 21 days * Access to a mobile phone and able to download app. Exclusion Criteria: * Known illicit drug use * Breast reduction or augmentation * Positive HIV status * Infant not expected to live \> 7 days following delivery * Has pacemaker
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Florida
Gainesville, Florida, 32610, United States