Breast Pumping
Conditions
Brief summary
The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.
Detailed description
This study aims to investigate whether the proposed changes to the INITIATE 2.0 program card lead to an improvement in comfort during pumping as well as increased milk removal during a pumping session. The results of this study will provide important information that a) validates the proposed changes as well as b) builds clear recommendations for which vacuum level should be used for Symphony program cards in this population.
Interventions
DEVICEbreast pumping as per SoC but on new software for the pump
breast pumping as per SoC but on new software for the pump
Sponsors
Medela AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
2 different groups, where 1 group does SoC (comparator device), the second uses the new device.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject ≥ 18 years old * Infant was born maximum 4 (96 hours) days ago * Subject aims to provide breastmilk for the baby through breastfeeding. * At least 50% of the milk removal sessions in the last 24hrs were breastfeeds. * Subject has an indication to pump for reasons * The subject signs the informed consent documentation
Exclusion criteria
* Woman is exclusively pumping * Woman is experiencing a mastitis event * Woman is still breastfeeding with the previous child * Woman has been breastfeeding in the last 6 months * Woman received morphine pain medication in the last 8 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events | during the 20 minutes pumping procedure. this is the only visit and task for the patient. | Number of patients with adverse events & description |
| Comfort while pumping | Within the 20 minutes pumping procedure. this is the only visit and task for the patient. | Assessed by the necessity of reducing the vacuum strength during pumping (binary outcome). It is expected that mothers should not need to change the vacuum strength when using the new program card |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the new software | during the 20 minutes pumping procedure. this is the only visit and task for the patient. | The output milk volume will be measured between the standard of care (pumping) approach and the new program card INITIATE 2.0 |
Countries
Netherlands
Outcome results
None listed