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NCT04619212: Initiate

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

Completed NA Last updated 25 March 2024
What this trial tests

NA trial testing breast pumping as per SoC but on new software for the pump in Breast Pumping in 80 participants. Completed in 7 September 2021.

Timeline
5 January 2021
Primary endpoint
7 September 2021
7 September 2021

Quick facts

Lead sponsorMedela AG
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment80
Start date5 January 2021
Primary completion7 September 2021
Estimated completion7 September 2021
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Medela AG

Who can join

18 and older, female only, with Breast Pumping. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An evaluation of patient comfort levels during expression with a modified pumping program: a prospective proof of concept study.
    Manshanden TMN, Prime DK, Scheele F, Velzel J. · · 2024 · cited 1× · PMID 38707635 · DOI 10.3389/fgwh.2024.1378263
  2. Impact of a Modified Breast Pump Suction Pattern on Milk Yield During the Initiation of Lactation: A pilot study.
    Nicole Manshanden TM, Prime DK, Scheele F, Velzel J. · · 2026 · PMID 41276904 · DOI 10.1097/jpn.0000000000000975

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Other Medela AG trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04619212.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing