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

NCT04619212 | Completed

• 1 other identifier: MHM_2003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Pumping

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Performance of the new software

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

Study Arms (2)

Standard of Care

OTHER

Standard of Care

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

new device

OTHER

new device

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

Interventions

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

Standard of Care; new device

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women can produce human milk
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medela AG: lead

Study Sites (1)

OLVG Amsterdam

Amsterdam, 1091, Netherlands

Location

Related Publications (2)

• Nicole Manshanden TM, Prime DK, Scheele F, Velzel J. Impact of a Modified Breast Pump Suction Pattern on Milk Yield During the Initiation of Lactation: A pilot study. J Perinat Neonatal Nurs. 2025 Nov 24. doi: 10.1097/JPN.0000000000000975. Online ahead of print.

  PMID: 41276904 DERIVED

• Manshanden TMN, Prime DK, Scheele F, Velzel J. An evaluation of patient comfort levels during expression with a modified pumping program: a prospective proof of concept study. Front Glob Womens Health. 2024 Apr 19;5:1378263. doi: 10.3389/fgwh.2024.1378263. eCollection 2024.

  PMID: 38707635 DERIVED

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Fedde Scheele

  Study team

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: January 5, 2021
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: March 25, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)