NCT03091985

Brief Summary

The purpose of this study is to investigate the efficacy of breast drainage of the healthy breast with the new Medela pump set breast shield (Brownie). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2017

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

March 15, 2017

Last Update Submit

February 7, 2020

Conditions

Lactation

Keywords

BreastshieldBreastpumpBreastfeeding

Outcome Measures

Primary Outcomes (1)

  • PAMR

    Breast drainage, determined by the metric percent of available milk removed (PAMR).

    7-21 days

Secondary Outcomes (4)

  • Milk volume

    After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.

  • Mid fat content

    After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.

  • Hind fat content

    After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.

  • Device usability

    After 15 minutes of controlled pumping with the test or comparator device. Each participant will pump twice with a "washout period" of 7-21 days in between the corresponding occasions.

Study Arms (2)

Group A

EXPERIMENTAL

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

Device: PersonalFit - Breast shieldDevice: Brownie - Breast shield

Group B

EXPERIMENTAL

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

Device: PersonalFit - Breast shieldDevice: Brownie - Breast shield

Interventions

PersonalFit - Breast shieldDEVICE

Subjects are to pump 15 min with the comparator device

Group AGroup B
Brownie - Breast shieldDEVICE

Subjects are to pump 15 min with the investigational device

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDue to the nature of the study device (breastshiled to be used for expressing breastmilk) only lactating females can be enrolled into the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject ≥ 18 years old
  • Infant is ≥1 and ≤6 month old
  • Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
  • 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
  • The subject agrees to photographs of the breast and upper body (no face)
  • The subject agrees to perform a 24 hour milk production at home, inclusive weighing the Infant before and after each feeding
  • The subject agrees to collect \~2 ml of milk before and after each feeding for fat analysis
  • The subject signed the Informed Consent Form

You may not qualify if:

  • Mastitis (any breast within two weeks prior enrolment)
  • Engorgement (any breast within two weeks prior enrolment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medela AG

Baar, Canton of Zug, 6341, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 32401335DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Lennart Ivarsson, PhD

    Employee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 27, 2017

Study Start

March 31, 2017

Primary Completion

September 30, 2017

Study Completion

December 19, 2017

Last Updated

February 10, 2020

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)