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

NCT ID: NCT06723067

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Premature Birth

Keywords

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premature birth lactation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Wearable wireless breast pump

Intervention Type DEVICE

As above

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.

Group Type OTHER

Wearable wireless breast pump

Intervention Type DEVICE

As above

Interventions

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Wearable wireless breast pump

As above

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan Groves

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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Ascension Seton Medical Center

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erica Ortiz

Role: CONTACT

Phone: 512-324-1085

Email: [email protected]

Facility Contacts

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Erica Ortiz

Role: primary

Other Identifiers

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STUDY00005474

Identifier Type: -

Identifier Source: org_study_id