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

January 21, 2025 updated by: Onze Lieve Vrouwe Gasthuis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pumping individual
Clinical indication for pumping
Device: 15 minutes pumping with INITIATE program
15 minutes pumping with INITIATE program
Device: 5 minutes extra pumping with MAINTAIN program
Additional 5 minutes extra pumping with MAINTAIN program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total expression volume in milliliter
Time Frame: T1= 15 minutes, T2=20 minutes
Expressed milk volume in milliliters between 15 and 20 minutes of pumping
T1= 15 minutes, T2=20 minutes

Secondary Outcome Measures

Outcome Measure
Time 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.
Time Frame: T1= 15 minutes, T2=20 minutes
T1= 15 minutes, T2=20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onze Lieve Vrouwe Gasthuis

Collaborators

Medela AG

Investigators

  • Principal Investigator: Fedde Scheele, Prof. Dr., OLVG hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Actual)

August 18, 2023

Study Completion (Actual)

August 18, 2023

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OLVG040
  • WO 22.168 (Other Identifier: OLVG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data is not shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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