Breast FeedingNCT04363073
Assessment of Annabella Breast Pump Performance
A study testing Annabella Breast Pump in people with Breast Feeding, run by Annabella Tech Ltd at 1 site in Israel.
Trial summary
This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump. 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 Feeding
- What is being tested?
- Annabella Breast Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Dec 2020to 31 Dec 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
- Women ≥ 18 years old
- Women whom are 2-5 months post delivery
- Lactating women - Breastfeed with no more than formula feeding twice a day and no solid food feeding (which replace breastfeeding) during the study period.
- Breastfeed or pumping at least 5 times a day
- Mother to healthy infant born at ≥ 37 weeks of gestation age.
Who cannot join
- Woman who consumes under 1,500 kcal/day (on a diet)
- Report a high mental stress condition and/or depression
- Use of estrogen oral contraceptives
- Pregnant women
- Suffer from chronic diseases that can impact breast feeding
- Participate in another clinical trial
Show all 9Show fewer
- Mothers of babies who may develop feeding difficulties according to the investigator decisions (such as cleft pallet, autism).
- Woman with Sunken/ flat nipple or inverted nipple. or any other physiological condition that may disturb breast feeding.
- Woman that declares at time of recruitment that she is unable to extract more than 25ml per breastfeeding (overall from both breast)
Trial locations and contacts
1 site in 1 country.
About this study
This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump.
Read the detailed description
50 women who are 2-5 months post-delivery will be included in the study following appropriate consent. Women will be randomly allocated to two groups for the type of pump used on the first session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. During each visit, milk will be expressed once a day from each of the two breasts (left \& right). During the 4 first visits (at least 1 day apart) Annabella or the control pump will be used. After at least 3 days washout period, milk will be expressed for additional 4 days, once a day from each of the two breasts, using the other breast pump. An expression session will last until no milk is expressed for 3 min continuously but not for longer than 25 min. Participants will be serving as their own control. Milk will be collected for volume and quality assessment. Maternal comfort at the end of each visit will be assessed using questionnaire.
- Conditions
- Breast Feeding
- Being tested
- Annabella Breast Pump, Control Breast Pump
- Keywords
- Breast Feeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annabella Breast PumpDevice
Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)
Control Breast PumpDevice
Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)
| Study group | Role | What they receive |
|---|---|---|
| Anaabella | Experimental | Milk will be expressed using Annabella breast pump. Receives: Device: Annabella Breast Pump |
| Control pump | Active comparator | Milk will be expressed using a control breast pump. Receives: Device: Control Breast Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Milk Volume collected using the breast pump
Total milk Volume (cc)
Measured: immediately after the intervention
Secondary outcomes (1)
Satisfaction Satisfaction questionnaires
rating scale: Min: 1 , Max: 10; higher score- better outcome
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start30 Dec 2020
- Primary completion1 Apr 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annabella Tech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Revital Sheinberg, MD, Principal investigator, Shiba Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363073
- Sponsor's protocol ID
- Annabella V1
- Status last verified
- Mar 2024
- First submitted
- 17 Apr 2020
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Annabella Breast Pump Performance
- ClinicalTrials.gov ID
- NCT04363073
- Acronym / sponsor ID
- Annabella V1
- Conditions
- Breast Feeding
- Keywords
- Breast Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Annabella Tech LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Apr 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.
This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump.
Detailed description
50 women who are 2-5 months post-delivery will be included in the study following appropriate consent. Women will be randomly allocated to two groups for the type of pump used on the first session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. During each visit, milk will be expressed once a day from each of the two breasts (left \& right). During the 4 first visits (at least 1 day apart) Annabella or the control pump will be used. After at least 3 days washout period, milk will be expressed for additional 4 days, once a day from each of the two breasts, using the other breast pump. An expression session will last until no milk is expressed for 3 min continuously but not for longer than 25 min. Participants will be serving as their own control. Milk will be collected for volume and quality assessment. Maternal comfort at the end of each visit will be assessed using questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anaabella | Experimental | Device: Annabella Breast PumpMilk will be expressed using Annabella breast pump. |
| Control pump | Active comparator | Device: Control Breast PumpMilk will be expressed using a control breast pump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women ≥ 18 years old
- Women whom are 2-5 months post delivery
- Lactating women - Breastfeed with no more than formula feeding twice a day and no solid food feeding (which replace breastfeeding) during the study period.
- Breastfeed or pumping at least 5 times a day
- Mother to healthy infant born at ≥ 37 weeks of gestation age.
Key exclusion criteria (9 listed)
- Woman who consumes under 1,500 kcal/day (on a diet)
- Report a high mental stress condition and/or depression
- Use of estrogen oral contraceptives
- Pregnant women
- Suffer from chronic diseases that can impact breast feeding
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 |
|---|---|---|
| Annabella Breast PumpMilk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart) | Device | Anaabella |
| Control Breast PumpMilk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart) | Device | Control pump |
Primary outcome
Milk Volume collected using the breast pump
Time frame: immediately after the intervention
Total milk Volume (cc)
1 secondary outcome
Satisfaction Satisfaction questionnaires
Time frame: immediately after the intervention
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 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Revital Sheinberg, MD principal investigator
Shiba Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annabella Breast Pump in people with Breast Feeding, run by Annabella Tech Ltd at 1 site in Israel.
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 5 inclusion and 9 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 26 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 Israel. 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?
Milk Volume collected using the breast pump (time frame: immediately after the intervention). 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 26 Mar 2024.