Breast PumpingNCT06222567
Assessing the Effect of an Additional 5 Minutes Pumping on Milk Output in the First Days After Delivery
A study testing 15 minutes pumping with INITIATE program and 5 minutes extra pumping with MAINTAIN program in people with Breast Pumping, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Pumping
- What is being tested?
- 15 minutes pumping with INITIATE program and 5 minutes extra pumping with MAINTAIN program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Feb 2023to 18 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Pumping
- Being tested
- 15 minutes pumping with INITIATE program, 5 minutes extra pumping with MAINTAIN program
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 minutes pumping with INITIATE programDevice
15 minutes pumping with INITIATE program
5 minutes extra pumping with MAINTAIN programDevice
Additional 5 minutes extra pumping with MAINTAIN program
| Study group | Role | What they receive |
|---|---|---|
| Pumping individual | Experimental | Clinical indication for pumping Receives: Device: 15 minutes pumping with INITIATE program; Device: 5 minutes extra pumping with MAINTAIN program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total expression volume in milliliter
Expressed milk volume in milliliters between 15 and 20 minutes of pumping
Measured: T1= 15 minutes, T2=20 minutes
Secondary outcomes (1)
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.
Measured: T1= 15 minutes, T2=20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start6 Feb 2023
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast PumpingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Medela AG
- Responsible party
- Sponsor
- Investigators
- Fedde Scheele, Prof. Dr., Principal investigator, OLVG Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222567
- Sponsor's protocol ID
- OLVG040
- Other IDs
- WO 22.168
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data is not shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Additional 5 Minutes Pumping on Expression Volume in Breastfeeding Human Initiating Breastfeeding.
- ClinicalTrials.gov ID
- NCT06222567
- Acronym / sponsor ID
- OLVG040
- Conditions
- Breast Pumping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Collaborators
- Medela AG
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pumping individual | Experimental | Device: 15 minutes pumping with INITIATE program, Device: 5 minutes extra pumping with MAINTAIN programClinical indication for pumping |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15 minutes pumping with INITIATE program15 minutes pumping with INITIATE program | Device | Pumping individual |
| 5 minutes extra pumping with MAINTAIN programAdditional 5 minutes extra pumping with MAINTAIN program | Device | Pumping individual |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No. Individual data is not shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fedde Scheele, Prof. Dr. principal investigator
OLVG Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 minutes pumping with INITIATE program and 5 minutes extra pumping with MAINTAIN program in people with Breast Pumping, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total expression volume in milliliter (time frame: T1= 15 minutes, T2=20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.