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

Purpose

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

Condition

  • Premature Birth

Eligibility

Eligible Ages
All ages
Eligible Sex
Female
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Ascension Seton Medical Center
Austin, Texas 78705
Contact:
Erica Ortiz
512-324-1085
erica.ortiz@ascension.org

More Details

Status
Recruiting
Sponsor
University of Texas at Austin

Study Contact

Erica Ortiz
512-324-1085
erica.ortiz@ascension.org

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.