A Randomized Controlled Trial of Impact of Wearable, Wireless Breast Pumps on Frequency and Efficacy of Milk Expression in Mothers of Premature Infants (MTMM)

December 3, 2024 updated by: University of Texas at Austin

More Time More Milk - Wearable, Wireless Breast Pumps to Increase Accessibility of Milk Expression for NICU Mothers

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized, controlled crossover study design. Non-blinded. Mother of infants born at or below 29+6 weeks of gestation will be eligible once their infant is 28 or more days old. Mothers will be provided with a wearable, wireless breast pump in addition to their usual hospital grade pump. Wireless pumps can be used while cuddling their baby, driving too and from the hospital, caring for other children, etc.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 mothers own wearable pump

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Wearable wireless pump provided in week one
Provision of a wearable, wireless pump in week one with support from a lactation specialist, standard of care in week two.
Device: Wearable wireless breast pump
As above
Other: Wearable wireless pump provided in week two
Standard of care in week one, provision of a wearable, wireless pump in week two with support from a lactation specialist.
Device: Wearable wireless breast pump
As above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of pumping sessions per day
Time Frame: 7 days
Number of milk pumping sessions per day
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of milk pumped per day
Time Frame: 7 days
Volume of breast milk pumped per day
7 days
Percentage of required volume pumped
Time Frame: 7 days
Percentage of infants daily required milk volume which was pumped per day
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Principal Investigator: Alan Groves, University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005474

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD can be shared at the request of other investigators

IPD Sharing Time Frame

12/02/2024, for 2 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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