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

Not Applicable

Recruiting

• Conditions: Premature Birth

• Registration Number: NCT06723067
• Lead Sponsor: University of Texas at Austin

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 Timeline

• Study Start: 2024-06-12
• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Number of pumping sessions per day	7 days	Number of milk pumping sessions per day

Secondary Outcome Measures

Name	Time	Method
Volume of milk pumped per day	7 days	Volume of breast milk pumped per day
Percentage of required volume pumped	7 days	Percentage of infants daily required milk volume which was pumped per day

Trial Locations

Locations (1)

Ascension Seton Medical Center; 🇺🇸 Austin, Texas, United States