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

Breast Pumping Clinical Trial

— Initiate  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04619212
• Other study ID #: MHM_2003
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: September 7, 2021

Study information

• Verified date: September 2021
• Source: Medela AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Pumping

Intervention

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

Locations

Country	Name	City	State
Netherlands	OLVG Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Medela AG

Country where clinical trial is conducted

Netherlands, 

Outcome

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.