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)

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.

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.

Study Overview

• Status: Completed
• Conditions: Breast Pumping
• Intervention / Treatment: Device: breast pumping as per SoC but on new software for the pump

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1091
    • OLVG Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

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.
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 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.

Collaborators and Investigators

• Sponsor: Medela AG
• Investigators: Principal Investigator: Fedde Scheele, Study team

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): September 7, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MHM_2003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual data is not shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No