- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06222567
Assessing the Effect of an Additional 5 Minutes Pumping on Milk Output in the First Days After Delivery
January 16, 2024 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
-
-
-
Amsterdam, Netherlands
- OLVG Hospital
-
-
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 aims to provide breastmilk for the baby through breastfeeding.
- At least 50% of the milk removal sessions in the last 24hrs were breastfeeds.
- Subject has an clinical indication to pump for reasons
- The subject signs the informed consent documentation
Exclusion Criteria:
- Woman is exclusively pumping
- Woman is still breastfeeding with the previous child
- Woman has been breastfeeding in the last 6 months
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
|
15 minutes pumping with INITIATE program
Additional 5 minutes extra pumping with MAINTAIN program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total expression volume in milliliter
Time Frame: T1= 15 minutes, T2=20 minutes
|
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)
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
Collaborators
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 (Estimated)
January 24, 2024
Study Record Updates
Last Update Posted (Estimated)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 16, 2024
Last Verified
January 1, 2024
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
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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