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

NCT ID: NCT06222567

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2023-08-18

Brief Summary

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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

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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.

Conditions

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Breast Pumping

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pumping individual

Clinical indication for pumping

Group Type EXPERIMENTAL

15 minutes pumping with INITIATE program

Intervention Type DEVICE

15 minutes pumping with INITIATE program

5 minutes extra pumping with MAINTAIN program

Intervention Type DEVICE

Additional 5 minutes extra pumping with MAINTAIN program

Interventions

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15 minutes pumping with INITIATE program

15 minutes pumping with INITIATE program

Intervention Type DEVICE

5 minutes extra pumping with MAINTAIN program

Additional 5 minutes extra pumping with MAINTAIN program

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medela AG

INDUSTRY

Sponsor Role collaborator

Onze Lieve Vrouwe Gasthuis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fedde Scheele, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

OLVG Hospital

Locations

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OLVG Hospital

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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WO 22.168

Identifier Type: OTHER

Identifier Source: secondary_id

OLVG040

Identifier Type: -

Identifier Source: org_study_id

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