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Completed

NCT Number: NCT05248828

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.

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Key information

Conditions

Breast Pumping Behavior Breast Feeding Breast Milk Expression Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Nemours Childrens Hospital Delaware

Wilmington, Delaware, 19803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Safety Rate

    Time frame: Immediately after steam bag sanitation

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

  2. Safety Rate

    Time frame: 24 hours later

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

Secondary outcomes

  1. Satisfaction Rate Questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2022
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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