Testing of New Method in Sanitizing Breast Pump Equipment in the NICU

Completed

• Conditions: Breast Pumping

• Registration Number: NCT05248828
• Lead Sponsor: Nemours Children's Clinic

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-02-10
• Study Start: 2022-02-21
• Study First Posted: 2022-02-21
• Primary Completion: 2022-02-25
• Study Completion: 2022-11-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

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

Inclusion Criteria

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

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Exclusion Criteria

• Mothers under the age of 18 years.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Rate	24 hours later	The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing

Secondary Outcome Measures

Name	Time	Method
Satisfaction Rate Questionnaire	At the end of 2 cycles (each cycle is 3 hours) of steam bag sanitation	The satisfaction rate is measured by participants comparing two different methods of breast pump part sanitation

Trial Locations

Locations (1)

Nemours Childrens Hospital Delaware; 🇺🇸 Wilmington, Delaware, United States