Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05248828 |
Other study ID # |
IRB1750118 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 21, 2022 |
Est. completion date |
November 1, 2022 |
Study information
Verified date |
March 2023 |
Source |
Nemours Children's Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Firstly, 10 participant's breast pump parts are collected, divided, washed, and dried before
comparing the two methods of steam sanitation. We will test to compare the safety of the Q.
Basin compared to the current method of steam bag sanitation. We will collect participant's
breast pump parts and complete surface swab testing for bacteria and mold immediately after
sanitation and additionally 24 hours later.
Secondly, 20 participant questionnaires will measure satisfaction ratings of participants
pumping human milk for hospitalized infants using two different wash, dry and steam
sanitation methods. This study design will determine if participant satisfaction improves
with breast pump part sanitation using the Q. Basin, compared to the current steam
sanitization bag method.