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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 (Initiate)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04619212
Recruitment Status : Completed
First Posted : November 6, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Medela AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Pumping Device: breast pumping as per SoC but on new software for the pump Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 different groups, where 1 group does SoC (comparator device), the second uses the new device.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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.
Actual Study Start Date : January 5, 2021
Actual Primary Completion Date : September 7, 2021
Actual Study Completion Date : September 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
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Arm Intervention/treatment
Standard of Care
Standard of Care
 Device: breast pumping as per SoC but on new software for the pump
breast pumping as per SoC but on new software for the pump
new device
new device
 Device: breast pumping as per SoC but on new software for the pump
breast pumping as per SoC but on new software for the pump


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: during the 20 minutes pumping procedure. this is the only visit and task for the patient. ]
    Number of patients with adverse events & description

  2. User acceptance of a longer-lasting program [ Time Frame: At the end of the 20 minutes pumping procedure. this is the only visit and task for the patient. ]
    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.


Secondary Outcome Measures :
  1. Performance of the new software [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women can produce human milk
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04619212


Locations
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Netherlands
OLVG Amsterdam
Amsterdam, Netherlands, 1091
Sponsors and Collaborators
Medela AG
Investigators
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Principal Investigator: Fedde Scheele Study team
More Information
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Responsible Party: Medela AG
ClinicalTrials.gov Identifier: NCT04619212    
Other Study ID Numbers: MHM_2003
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual data is not shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No