An observational study in Breast Pumping, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Nemours Children's Clinic · Observational
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.
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.
Nemours Children's Clinic is the lead sponsor of 127 studies on the registry; 27 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Safety Rate
The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing
Time frame: Immediately after steam bag sanitation
Safety Rate
The Safety rate between the Q. Basin and steam bag sanitation is measured by surface swab testing
Time frame: 24 hours later
Satisfaction Rate Questionnaire
The satisfaction rate is measured by participants comparing two different methods of breast pump part sanitation
Time frame: At the end of 2 cycles (each cycle is 3 hours) of steam bag sanitation
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Nemours Children's Clinic