Influence of the Brownie Breast Shield on the Dynamics of Milk Removal
NCT ID: NCT03091985
Last Updated: 2020-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2017-03-31
2017-12-19
Brief Summary
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The objective of the study is to verify the Brownie breast shield to be non-inferior to the current PersonalFit breast shield in emptying the healthy lactating breast.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group A
Drainage of the lactating breast using:
PersonalFit - Breast shield \& Brownie - Breast shield
Breast shields are each to be used for 15 min pumping with the symphony breastpump
PersonalFit - Breast shield
Subjects are to pump 15 min with the comparator device
Brownie - Breast shield
Subjects are to pump 15 min with the investigational device
Group B
Drainage of the lactating breast using:
Brownie - Breast shield \& PersonalFit - Breast shield
Breast shields are each to be used for 15 min pumping with the symphony breastpump
PersonalFit - Breast shield
Subjects are to pump 15 min with the comparator device
Brownie - Breast shield
Subjects are to pump 15 min with the investigational device
Interventions
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PersonalFit - Breast shield
Subjects are to pump 15 min with the comparator device
Brownie - Breast shield
Subjects are to pump 15 min with the investigational device
Eligibility Criteria
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Inclusion Criteria
2. Infant is ≥1 and ≤6 month old
3. Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
4. The subject agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping session at the study site
5. The subject agrees to photographs of the breast and upper body (no face)
6. The subject agrees to perform a 24 hour milk production at home, inclusive weighing the Infant before and after each feeding
7. The subject agrees to collect \~2 ml of milk before and after each feeding for fat analysis
8. The subject signed the Informed Consent Form
Exclusion Criteria
2. Engorgement (any breast within two weeks prior enrolment)
18 Years
FEMALE
Yes
Sponsors
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Clinical Trial Unit, University Hospital Basel, Switzerland
OTHER
Medela AG
INDUSTRY
Responsible Party
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Principal Investigators
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Lennart Ivarsson, PhD
Role: PRINCIPAL_INVESTIGATOR
Employee
Locations
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Medela AG
Baar, Canton of Zug, Switzerland
Countries
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References
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Sakalidis VS, Ivarsson L, Haynes AG, Jager L, Scharer-Hernandez NG, Mitoulas LR, Prime DK. Breast shield design impacts milk removal dynamics during pumping: A randomized controlled non-inferiority trial. Acta Obstet Gynecol Scand. 2020 Nov;99(11):1561-1567. doi: 10.1111/aogs.13897. Epub 2020 Jun 5.
Other Identifiers
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MHM1601
Identifier Type: -
Identifier Source: org_study_id
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