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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Other | Standard of Care |
|
| new device | Other | new device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| breast pumping as per SoC but on new software for the pump | Device | breast pumping as per SoC but on new software for the pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | Number of patients with adverse events & description | during the 20 minutes pumping procedure. this is the only visit and task for the patient. |
| Comfort while pumping | 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 | Within the 20 minutes pumping procedure. this is the only visit and task for the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the new software | The output milk volume will be measured between the standard of care (pumping) approach and the new program card INITIATE 2.0 | during the 20 minutes pumping procedure. this is the only visit and task for the patient. |
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Inclusion Criteria:
Exclusion Criteria:
Only women can produce human milk
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| Name | Affiliation | Role |
|---|---|---|
| Fedde Scheele | Study team | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVG Amsterdam | Amsterdam | 1091 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41276904 | Derived | Nicole Manshanden TM, Prime DK, Scheele F, Velzel J. Impact of a Modified Breast Pump Suction Pattern on Milk Yield During the Initiation of Lactation: A pilot study. J Perinat Neonatal Nurs. 2026 Apr-Jun 01;40(2):129-136. doi: 10.1097/JPN.0000000000000975. Epub 2025 Nov 24. | |
| 38707635 | Derived | Manshanden TMN, Prime DK, Scheele F, Velzel J. An evaluation of patient comfort levels during expression with a modified pumping program: a prospective proof of concept study. Front Glob Womens Health. 2024 Apr 19;5:1378263. doi: 10.3389/fgwh.2024.1378263. eCollection 2024. |
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individual data is not shared.
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2 different groups, where 1 group does SoC (comparator device), the second uses the new device.
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| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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