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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05248828

Enrollment

Registered

2022-02-21

Start date

2022-02-21

Completion date

2022-11-01

Last updated

2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Pumping

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety Rate	Immediately after steam bag sanitation	The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results