Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04619212
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2020-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Medela AG
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Initiate
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: