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Assessing the Effect of an Additional 5 Minutes Pumping on Milk Output in the First Days After Delivery

Assessing the Effect of Additional 5 Minutes Pumping on Expression Volume in Breastfeeding Human Initiating Breastfeeding.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06222567
Enrollment
90
Registered
2024-01-24
Start date
2023-02-06
Completion date
2023-08-18
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Pumping

Brief summary

The study hypothesizes that human who are both breastfeeding and pumping in the first days postpartum have more expression volume with an additional 5 minutes of pumping with Maintain program after pumping with the INITIATE program.

Detailed description

This study aims to assess if expression milk volume could be improved for patients pumping milk for a clinical indication by implementing five minutes more pumping with the MAINTAIN program, a different sucking pattern, to initiate and benefit milk production. The results of this study will provide important information that validates the proposed changes as well as build clear recommendation for using the Symphony program cards in this population.

Interventions

DEVICE15 minutes pumping with INITIATE program

15 minutes pumping with INITIATE program

DEVICE5 minutes extra pumping with MAINTAIN program

Additional 5 minutes extra pumping with MAINTAIN program

Sponsors

Medela AG
CollaboratorINDUSTRY
Onze Lieve Vrouwe Gasthuis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Subject ≥ 18 years old * Infant was born maximum 4 (96 hours) days ago * Subject has an clinical indication to pump for reasons * The subject signs the informed consent documentation

Design outcomes

Primary

MeasureTime frameDescription
Total expression volume in milliliterT1= 15 minutes, T2=20 minutesExpressed milk volume in milliliters between 15 and 20 minutes of pumping

Secondary

MeasureTime frame
Total expression volume in milliliters according to postpartum inclusion day (day 1,2,3 or 4) and patient characteristic. Milk yielded in milliliters per minute after 15 and 20 minutes pumping.T1= 15 minutes, T2=20 minutes

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026