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

Medela

Status: Completed

Conditions: Breast Pumping

Treatments: Device: breast pumping as per SoC but on new software for the pump

Study type: Interventional

Funder types: Industry

Identifiers

NCT04619212

MHM_2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Standard of Care

Other group

Description:

Standard of Care

Treatment:

Device: breast pumping as per SoC but on new software for the pump

new device

Other group

Description:

new device

Treatment:

Device: breast pumping as per SoC but on new software for the pump