NCT04619212

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Medela AG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Breast Pumping

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-05
• Primary completion: 2021-09-07
• Completion: 2021-09-07
• First posted: 2020-11-06
• Last updated: 2024-03-25

Locations

1 site across 1 country: Netherlands