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

The University of Texas System (UT)

Status: Enrolling

Conditions: Premature Birth

Treatments: Device: Wearable wireless breast pump

Study type: Interventional

Funder types: Other

Identifiers

NCT06723067

STUDY00005474

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Wearable wireless pump provided in week one

Other group

Description:

Provision of a wearable, wireless pump in week one with support from a lactation specialist, standard of care in week two.

Treatment:

Device: Wearable wireless breast pump

Wearable wireless pump provided in week two

Other group

Description:

Standard of care in week one, provision of a wearable, wireless pump in week two with support from a lactation specialist.

Treatment:

Device: Wearable wireless breast pump