Breast PumpingNCT05297799
Clinical Validation of the Ameda Pearl - An Electric, Hospital Grade, Multi-User Breast Pump
A study testing Ameda Pearl breast pump in people with Breast Pumping, run by Ameda, Inc. at 1 site in United States.
Trial summary
This study introduces a new Ameda electric multi-user, hospital-grade breast pump, the Ameda Pearl, to mothers who choose to exclusively breast pump until their infants are able to breastfeed. 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?
- Ameda Pearl breast pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to Sep 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
- Delivered an infant >28 weeks gestational age
- Infant is unlikely to be developmentally ready to breastfeed until >2 weeks old
- Wish to initiate lactation and express breast milk for at least two weeks, exclusively using the study pump
- Started or plan to start pumping within six hours of delivery
- Agree to double pump with study pump to express breast milk at least 8 times per 24 hours for a minimum of 15 minutes each session during the study participation period
- Read and understand the English language
- Adults, over or equal to the age of 18 are being recruited in this study so consent can be given by the participant directly. These potential participants could be included in the study if their infants were born in the third trimester, greater than or equal to 28 weeks gestational age, and were unable to breastfeed due to prematurity, developmental stage and/or physical anomalies preventing their ability to breastfeed directly at the breast.
Who cannot join
- Have had breast reduction surgery
- Have a history of low milk production
- Have any medical or physical condition that in the opinion of the investigator would prevent them from participating in the study
- Are currently breastfeeding another child
- Fail the initial Investigator Breast Tissue Assessment (Attachment #4)
- Have begun breast pumping with another breast pump to express breast milk
- Are taking any medications or supplements that are meant to alter milk supply volume
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Summa Health
Akron, Ohio, 44304
Susan M Shondel, MD, 330-571-9889, shondels@summahealth.org
About this study
Official title: Clinical Validation of the Ameda Pearl Breast Pump
This study introduces a new Ameda electric multi-user, hospital-grade breast pump, the Ameda Pearl, to mothers who choose to exclusively breast pump until their infants are able to breastfeed.
Read the detailed description
The purpose of this study is to determine whether exclusively pumping mothers of hospitalized infants greater than or equal to 28 weeks gestational age can come to volume, defined as a minimum of 500ml/24 hours, while using the Ameda Pearl breast pump during the first 14 days postpartum.
The Ameda Pearl has a stimulation and expression mode, as well as separate speed (30-120 cycles per minute) and suction (-30 to -250 mmHg) push-button controls that are adjustable in each mode.
Study data will include daily milk volumes, suction pressures, pumping times, ending speeds and comfort by mothers of preterm infants to determine if the pump facilitates achievement of 'coming to volume' status.
- Conditions
- Breast Pumping
- Being tested
- Ameda Pearl breast 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.
Ameda Pearl breast pumpDevice
The Ameda Pearl breast pump is a powered, multi-user breast pump with stimulation and expression modes and independently user-selectable speed and suction control in each mode.
| Study group | Role | What they receive |
|---|---|---|
| Lactating women | Experimental | New mothers whose infants born after 28 weeks gestational age are unable to breastfeed will exclusively breast pump their breast milk with an Ameda Pearl breast pump for a minimum of the first 14 days postpartum. Receives: Device: Ameda Pearl breast pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
milk volume
milk volume pumped during multiple sessions over a 24-hour period
Measured: At day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start21 Jul 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lactating women
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ameda, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan M Shondel, MD, Principal investigator, Summa Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297799
- Sponsor's protocol ID
- HGP2022
- Status last verified
- Jan 2023
- First submitted
- 26 Feb 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Ameda Pearl Breast Pump
- ClinicalTrials.gov ID
- NCT05297799
- Acronym / sponsor ID
- HGP2022
- Conditions
- Breast Pumping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ameda, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 28 Mar 2022 (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 study introduces a new Ameda electric multi-user, hospital-grade breast pump, the Ameda Pearl, to mothers who choose to exclusively breast pump until their infants are able to breastfeed.
Detailed description
The purpose of this study is to determine whether exclusively pumping mothers of hospitalized infants greater than or equal to 28 weeks gestational age can come to volume, defined as a minimum of 500ml/24 hours, while using the Ameda Pearl breast pump during the first 14 days postpartum.
The Ameda Pearl has a stimulation and expression mode, as well as separate speed (30-120 cycles per minute) and suction (-30 to -250 mmHg) push-button controls that are adjustable in each mode.
Study data will include daily milk volumes, suction pressures, pumping times, ending speeds and comfort by mothers of preterm infants to determine if the pump facilitates achievement of 'coming to volume' status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lactating women
| Arm | Type | Receives |
|---|---|---|
| Lactating women | Experimental | Device: Ameda Pearl breast pumpNew mothers whose infants born after 28 weeks gestational age are unable to breastfeed will exclusively breast pump their breast milk with an Ameda Pearl breast pump for a minimum of the first 14 days postpartum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Delivered an infant >28 weeks gestational age
- Infant is unlikely to be developmentally ready to breastfeed until >2 weeks old
- Wish to initiate lactation and express breast milk for at least two weeks, exclusively using the study pump
- Started or plan to start pumping within six hours of delivery
- Agree to double pump with study pump to express breast milk at least 8 times per 24 hours for a minimum of 15 minutes each session during the study participation period
Key exclusion criteria (7 listed)
- Have had breast reduction surgery
- Have a history of low milk production
- Have any medical or physical condition that in the opinion of the investigator would prevent them from participating in the study
- Are currently breastfeeding another child
- Fail the initial Investigator Breast Tissue Assessment (Attachment #4)
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 |
|---|---|---|
| Ameda Pearl breast pumpThe Ameda Pearl breast pump is a powered, multi-user breast pump with stimulation and expression modes and independently user-selectable speed and suction control in each mode. | Device | Lactating women |
Primary outcome
milk volume
Time frame: At day 14
milk volume pumped during multiple sessions over a 24-hour period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- 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.
Susan M Shondel, MD principal investigator
Summa Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ameda Pearl breast pump in people with Breast Pumping, run by Ameda, Inc. at 1 site in United States.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan M Shondel, MD (330-571-9889, shondels@summahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
milk volume (time frame: At day 14). 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 20 Jan 2023.