Breast Pumping Clinical Trial
— InitiateOfficial title:
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.
Verified date | September 2021 |
Source | Medela AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 7, 2021 |
Est. primary completion date | September 7, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | OLVG Amsterdam | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Medela AG |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Secondary | 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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