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

Breast Pumping Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248828
• Other study ID #: IRB1750118
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Pumping

Locations

Country	Name	City	State
United States	Nemours Childrens Hospital Delaware	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Rate	The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing	Immediately after steam bag sanitation
Primary	Safety Rate	The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing	24 hours later
Secondary	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