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Insufficient LactationNCT05147987

Improving Lactation Success in Black Mothers of Critically Ill Infants

A study testing Hands free wearable breast pump in people with Insufficient Lactation, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Racial disparities result in Black infants in the neonatal intensive care unit (NICU) receiving less breast milk (BM) than White and Hispanic infants.1 BM improves infant health yet mothers of critically ill infants produce insufficient amounts to provide these benefits which is likely due to inadequate daily breast… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Insufficient Lactation
What is being tested?
Hands free wearable breast pump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
1 Jan 2022to 15 Feb 2025
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Known illicit drug use
  • Breast reduction or augmentation
  • Positive HIV status
  • Infant not expected to live > 7 days following delivery
  • Has pacemaker

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Florida

    Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: Improving Lactation Success in Black Mothers of Critically Ill Infants in the NICU Using Discreet, Hands-free, Wearable Breast Pumps

Racial disparities result in Black infants in the neonatal intensive care unit (NICU) receiving less breast milk (BM) than White and Hispanic infants.1 BM improves infant health yet mothers of critically ill infants produce insufficient amounts to provide these benefits which is likely due to inadequate daily breast pumping frequency. Black mothers face unique challenges to frequent breast pumping including returning to work earlier, working in facilities with inadequate lactation support, and limited privacy for breast pumping at home. Therefore, the objective of this pilot study is to determine the feasibility and potential benefits of using a discreet, hands-free, wearable breast pump with an associated App that tracks pumping frequency and BM production to increase lactation success in Black mothers of infants admitted to the NICU. Specific aims include (1) evaluate the feasibility of a discreet, hands-free, wearable pump in Black mothers of critically ill infants to increase pumping frequency and BM production and (2) assess whether results indicate a signal of effectiveness supporting a subsequent adequately powered randomized clinical trial (RCT). Following delivery, 40 Black mothers of critically ill infants will be randomized to one of two groups. Group 1 will be provided a discreet, hands-free, wearable breast pump with an associated App and Group 2 will be provided a standard mechanical breast pump with no associated App. Results will be used to revise the intervention and study processes and to estimate outcome measurement variability and effect sizes needed for sample size calculations for an adequately powered RCT.

Being tested
Hands free wearable breast pump
Medical subject headings
Lactation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hands free wearable breast pumpDevice

    Use of a supplementary breast pump which can be discreetly worn and is hands free

Study groups in NCT05147987
Study groupRoleWhat they receive
Intervention GroupExperimentalWill be provided a discreet, hands-free, wearable breast pump with an associated App
Receives: Device: Hands free wearable breast pump
Standard care groupNo interventionWill be provided a standard mechanical breast pump with no associated App.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Acceptance of the Intervention

    Survey questions regarding the number of participant acceptance of intervention

    Measured: at 20-22 days

Secondary outcomes (4)
  1. Pumped Milk Volume

    Volume of Pumped milk volume

    Measured: up to 21 days

  2. Days to Secretory Activation

    Time from birth to a milk sodium level < 20mMol

    Measured: Up to 21 days

  3. Total Pumping Sessions

    Total pumping sessions over 21 days

    Measured: up to 21 days

  4. Lactation Duration

    how long mothers continue lactating

    Measured: up to 100 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2021
  2. Study start1 Jan 2022
  3. Primary completion15 Feb 2025
  4. Study completion15 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05147987
Sponsor's protocol ID
IRB202102029
Status last verified
Nov 2024
First submitted
8 Nov 2021
Last updated
9 Sep 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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