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

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.

Study Overview

• Status: Completed
• Conditions: Breast Pumping

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours Childrens Hospital Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Mothers under the age of 18 years.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Investigators: Principal Investigator: Marron, Nemours Childrens Health- Delaware

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB1750118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No