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Completed

NCT Number: NCT04619212

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

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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Key information

Conditions

Breast Pumping Behavior Breast Feeding Breast Milk Expression Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OLVG Amsterdam

Amsterdam, 1091, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Occurrence of adverse events

    Time frame: during the 20 minutes pumping procedure. this is the only visit and task for the patient.

    Number of patients with adverse events & description

  2. Comfort while pumping

    Time frame: 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 outcomes

  1. Performance of the new software

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medela AG

Industry

Registry information

Official study 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.

Acronym: Initiate

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2020
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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