More Time More Milk - Wearable, Wireless Breast Pumps to Increase Accessibility of Milk Expression for NICU Mothers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of pumping sessions per day
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- 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
Arms & Interventions
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.
Intervention: Wearable wireless breast pump (Device)
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.
Intervention: Wearable wireless breast pump (Device)
Outcomes
Primary Outcomes
Number of pumping sessions per day
Time Frame: 7 days
Number of milk pumping sessions per day
Secondary Outcomes
- Volume of milk pumped per day(7 days)
- Percentage of required volume pumped(7 days)