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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2021-09-07

Brief Summary

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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.

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Detailed Description

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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

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Breast Pumping

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

2 different groups, where 1 group does SoC (comparator device), the second uses the new device.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of Care

Group Type OTHER

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

Intervention Type DEVICE

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

new device

Group Type OTHER

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

Intervention Type DEVICE

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

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes