NCT06723067

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

December 3, 2024

Last Update Submit

December 3, 2024

Conditions

Premature Birth

Keywords

premature birthlactation

Outcome Measures

Primary Outcomes (1)

  • Number of pumping sessions per day

    Number of milk pumping sessions per day

    7 days

Secondary Outcomes (2)

  • Volume of milk pumped per day

    7 days

  • Percentage of required volume pumped

    7 days

Study Arms (2)

Wearable wireless pump provided in week one

OTHER

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

Wearable wireless pump provided in week two

OTHER

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

Interventions

Wearable wireless breast pumpDEVICE

As above

Wearable wireless pump provided in week oneWearable wireless pump provided in week two

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mother of infant born at 29+6 weeks or below
  • Mother still pumping at 4 weeks since birth

You may not qualify if:

  • Current use of mothers own wearable pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ascension Seton Medical Center

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

Premature BirthBreast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Officials

  • Alan Groves

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Ortiz

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 9, 2024

Study Start

June 12, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

IPD can be shared at the request of other investigators

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
12/02/2024, for 2 years

Locations

US(1)