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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
breast pumping as per SoC but on new software for the pump
OLVG Amsterdam
Amsterdam, Netherlands
Occurrence of adverse events
Number of patients with adverse events \& description
Time frame: 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
Time frame: Within the 20 minutes pumping procedure. this is the only visit and task for the patient.
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
Time frame: during the 20 minutes pumping procedure. this is the only visit and task for the patient.
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