Lactation
Conditions
Keywords
Breastshield, Breastpump, Breastfeeding
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.
Detailed description
In this study we could show that the Brownie shield is non-inferior to the PersonalFit shield in all four endpoints, superior to the PersonalFit shield in terms of PAMR and expressed milk volume, and is more comfortable than the PersonalFit shield according to participant surveys.
Interventions
DEVICEPersonalFit - Breast shield
Subjects are to pump 15 min with the comparator device
DEVICEBrownie - Breast shield
Subjects are to pump 15 min with the investigational device
Sponsors
Clinical Trial Unit, University Hospital Basel, Switzerland
Medela AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject ≥ 18 years old 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
1. Mastitis (any breast within two weeks prior enrolment) 2. Engorgement (any breast within two weeks prior enrolment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAMR | 7-21 days | Breast drainage, determined by the metric percent of available milk removed (PAMR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Expressed breast milk volume |
| 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. | Breast milk - mid fat content |
| 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. | Breast milk - hind fat content |
| 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. | Device usability questionnaire |
Countries
Switzerland
Outcome results
None listed