Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pre-market, Prospective, Comparative, Concept Proofing, Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card INITIATE 2.0 Program Compared With the Current Standard of Care, the Symphony Plus Program Card.

Conditions
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Breast Pumping

Intervention / Treatment
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* Device: breast pumping as per SoC but on new software for the pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 different groups, where 1 group does SoC (comparator device), the second uses the new device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care<br>Standard of Care | Device: breast pumping as per SoC but on new software for the pump<br>* breast pumping as per SoC but on new software for the pump<br>|
| Other: new device<br>new device | Device: breast pumping as per SoC but on new software for the pump<br>* breast pumping as per SoC but on new software for the pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 
| User acceptance of a longer-lasting program | Participants will answer questions in a questionnaire. The user acceptance of the new card is assessed by a questionnaire, with the outcome measured on a five-point Likert scale. The five-point Likert scale will be used to compare mothers using the old program card and the new program card. | At the end of the 20 minutes pumping procedure. this is the only visit and task for the patient. | 

Secondary Outcome Measures

| Outcome Measure | 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. |