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

Not Applicable

Completed

• Conditions: Breast Pumping
• Interventions: Device: breast pumping as per SoC but on new software for the pump

• Registration Number: NCT04619212
• Lead Sponsor: Medela AG

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 Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-06
• Study Start: 2021-01-05
• Status Verified: 2021-09
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-07
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
new device	breast pumping as per SoC but on new software for the pump	new device
Standard of Care	breast pumping as per SoC but on new software for the pump	Standard of Care

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	during the 20 minutes pumping procedure. this is the only visit and task for the patient.	Number of patients with adverse events \& description
Comfort while pumping	Within the 20 minutes pumping procedure. this is the only visit and task for the patient.	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

Secondary Outcome Measures

Name	Time	Method
Performance of the new software	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

Trial Locations

Locations (1)

OLVG Amsterdam; 🇳🇱 Amsterdam, Netherlands