A Randomized Controlled Trial of Impact of Wearable, Wireless Breast Pumps on Frequency and Efficacy of Milk Expression in Mothers of Premature Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wearable wireless breast pump.
- Who it may be relevant to
- Registry conditions: Premature Birth. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
More Time More Milk - Wearable, Wireless Breast Pumps to Increase Accessibility of Milk Expression for NICU Mothers
Overview
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.
Interventions
- Device Wearable wireless breast pump
As above
Primary outcome measures
- Number of pumping sessions per day [Time frame: 7 days]
Secondary outcome measures (2)
- Volume of milk pumped per day [Time frame: 7 days]
- Percentage of required volume pumped [Time frame: 7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Ascension Seton Medical Center — Austin
Identifiers
NCT: NCT06723067 · STUDY00005474