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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
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.
7 September 2021
Quick facts
| Lead sponsor | Medela AG |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 80 |
| Start date | 5 January 2021 |
| Primary completion | 7 September 2021 |
| Estimated completion | 7 September 2021 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- breast pumping as per SoC but on new software for the pump
Conditions studied
- Breast Pumping — all drugs for Breast Pumping →
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT04619212
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Medela AG trials
Trials by the same sponsor.
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- NCT03921918 — Evaluation of Fluid-Filled Expression Core Technology Study - I · NA · completed
- NCT03670225 — Evaluating Clinical Acceptance of a NPWT Wound Care System · NA · completed
- NCT03091985 — Influence of the Brownie Breast Shield on the Dynamics of Milk Removal · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04619212 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medela AG
- Last refreshed: 25 March 2024
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