NCT05248828

Brief Summary

This study will evaluate a newly developed device, Q. Basin. The Q. Basin is a multifunctional, single patient use device that can sanitize breast pump parts, bottles, and reusable feeding devices for patients admitted under one year of age. Improving the current sanitation method would provide a quick and efficient sanitation process for breast pump parts. This study will compare the Q. Basin to the current method of steam bag sanitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 26, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

4 days

First QC Date

January 26, 2022

Last Update Submit

March 24, 2023

Conditions

Breast Pumping

Outcome Measures

Primary Outcomes (2)

  • Safety Rate

    The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing

    Immediately after steam bag sanitation

  • Safety Rate

    The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing

    24 hours later

Secondary Outcomes (1)

  • Satisfaction Rate Questionnaire

    At the end of 2 cycles (each cycle is 3 hours) of steam bag sanitation

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMothers who are pumping human milk for hospitalized infants in the Neonatal Intensive Care Unit
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In the Neonatal Intensive Care Unit, mothers who wish to pump human milk for their hospitalized infant do so with an electric breast pump. All 10 breast pump parts are used to pump human milk 8-10 times a day. After each pumping session, breast pump parts that contact human milk are washed and air-dried thoroughly until next use. Once a day, clean pump parts are placed in a sanitation bag and steam sanitized in the microwave.

You may qualify if:

  • Mothers who are pumping human milk for hospitalized infants in the Neonatal Intensive Care Unit.

You may not qualify if:

  • Mothers under the age of 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours Childrens Hospital Delaware

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Study Officials

  • Marron

    Nemours Childrens Health- Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 21, 2022

Study Start

February 21, 2022

Primary Completion

February 25, 2022

Study Completion

November 1, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

US(1)