Breast PumpingInitiateNCT04619212
Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card
A study testing breast pumping as per SoC but on new software for the pump in people with Breast Pumping, run by Medela AG at 1 site in Netherlands.
Trial summary
The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care. 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?
- breast pumping as per SoC but on new software for the pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jan 2021to 7 Sep 2021
- 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 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 indication to pump for reasons
- The subject signs the informed consent documentation
Who cannot join
- Woman is exclusively pumping
- Woman is experiencing a mastitis event
- Woman is still breastfeeding with the previous child
- Woman has been breastfeeding in the last 6 months
- Woman received morphine pain medication in the last 8 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pre-market, Prospective, Comparative, Concept Proofing, Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card INITIATE 2.0 Program Compared With the Current Standard of Care, the Symphony Plus Program Card.
The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.
Read the detailed description
This study aims to investigate whether the proposed changes to the INITIATE 2.0 program card lead to an improvement in comfort during pumping as well as increased milk removal during a pumping session. The results of this study will provide important information that a) validates the proposed changes as well as b) builds clear recommendations for which vacuum level should be used for Symphony program cards in this population.
- Conditions
- Breast Pumping
- Being tested
- breast pumping as per SoC but on new software for the pump
- 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.
breast pumping as per SoC but on new software for the pumpDevice
breast pumping as per SoC but on new software for the pump
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Standard of Care Receives: Device: breast pumping as per SoC but on new software for the pump |
| new device | Other | new device Receives: Device: breast pumping as per SoC but on new software for the pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Number of patients with adverse events \& description
Measured: during the 20 minutes pumping procedure. this is the only visit and task for the patient.
Comfort while pumping
Assessed by the necessity of reducing the vacuum strength during pumping (binary outcome). It is expected that mothers should not need to change the vacuum strength when using the new program card
Measured: Within the 20 minutes pumping procedure. this is the only visit and task for the patient.
Secondary outcomes (1)
Performance of the new software
The output milk volume will be measured between the standard of care (pumping) approach and the new program card INITIATE 2.0
Measured: during the 20 minutes pumping procedure. this is the only visit and task for the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start5 Jan 2021
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 different groups, where 1 group does SoC (comparator device), the second uses the new device.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medela AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fedde Scheele, Principal investigator, Study team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619212
- Sponsor's protocol ID
- MHM_2003
- Acronym
- Initiate
- Status last verified
- Sep 2021
- First submitted
- 2 Nov 2020
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual data is not shared.
Publications
Nicole Manshanden TM, Prime DK, Scheele F, Velzel J. Impact of a Modified Breast Pump Suction Pattern on Milk Yield During the Initiation of Lactation: A pilot study. J Perinat Neonatal Nurs. 2026 Apr-Jun 01;40(2):129-136. doi: 10.1097/JPN.0000000000000975. Epub 2025 Nov 24.
PubMed 41276904Manshanden TMN, Prime DK, Scheele F, Velzel J. An evaluation of patient comfort levels during expression with a modified pumping program: a prospective proof of concept study. Front Glob Womens Health. 2024 Apr 19;5:1378263. doi: 10.3389/fgwh.2024.1378263. eCollection 2024.
PubMed 38707635
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-market, Prospective, Comparative, Concept Proofing, Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card INITIATE 2.0 Program Compared With the Current Standard of Care, the Symphony Plus Program Card.
- ClinicalTrials.gov ID
- NCT04619212
- Acronym / sponsor ID
- Initiate / MHM_2003
- Conditions
- Breast Pumping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medela AGIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 6 Nov 2020 (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 mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.
Detailed description
This study aims to investigate whether the proposed changes to the INITIATE 2.0 program card lead to an improvement in comfort during pumping as well as increased milk removal during a pumping session. The results of this study will provide important information that a) validates the proposed changes as well as b) builds clear recommendations for which vacuum level should be used for Symphony program cards in this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 different groups, where 1 group does SoC (comparator device), the second uses the new device.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Device: breast pumping as per SoC but on new software for the pumpStandard of Care |
| new device | Other | Device: breast pumping as per SoC but on new software for the pumpnew device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 indication to pump for reasons
Key exclusion criteria (5 listed)
- Woman is exclusively pumping
- Woman is experiencing a mastitis event
- Woman is still breastfeeding with the previous child
- Woman has been breastfeeding in the last 6 months
- Woman received morphine pain medication in the last 8 hours
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 |
|---|---|---|
| breast pumping as per SoC but on new software for the pumpbreast pumping as per SoC but on new software for the pump | Device | Standard of Care, new device |
Primary outcome
Occurrence of adverse events
Time frame: during the 20 minutes pumping procedure. this is the only visit and task for the patient.
Number of patients with adverse events \& description
Comfort while pumping
Time frame: Within the 20 minutes pumping procedure. this is the only visit and task for the patient.
Assessed by the necessity of reducing the vacuum strength during pumping (binary outcome). It is expected that mothers should not need to change the vacuum strength when using the new program card
1 secondary outcome
Performance of the new software
Time frame: during the 20 minutes pumping procedure. this is the only visit and task for the patient.
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 25 Mar 2024.
- Derived from this study: PubMed 41276904Nicole Manshanden TM, Prime DK, Scheele F, Velzel J. Impact of a Modified Breast Pump Suction Pattern on Milk Yield During the Initiation of Lactation: A pilot study. J Perinat Neonatal Nurs. 2026 Apr-Jun 01;40(2):129-136. doi: 10.1097/JPN.0000000000000975. Epub 2025 Nov 24.
- Derived from this study: PubMed 38707635Manshanden TMN, Prime DK, Scheele F, Velzel J. An evaluation of patient comfort levels during expression with a modified pumping program: a prospective proof of concept study. Front Glob Womens Health. 2024 Apr 19;5:1378263. doi: 10.3389/fgwh.2024.1378263. eCollection 2024.
- 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 principal investigator
Study team
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast pumping as per SoC but on new software for the pump in people with Breast Pumping, run by Medela AG 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 6 inclusion and 5 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 25 Mar 2024. 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?
Occurrence of adverse events (time frame: during the 20 minutes pumping procedure. this is the only visit and task for the patient.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04619212, which also lists 2 linked publications.
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 25 Mar 2024.