Volume of Breast Milk Expressed Using Single Electric Breast Pumps.NCT02128295
Trial of Two Electric Breast Pumps in Mothers of Term Infants.
A study testing Electric breast pump - A and Electric breast pump - B in people with Volume of Breast Milk Expressed Using Single Electric Breast Pumps. and Duration of Exclusive Breast-feeding, run by University College, London at 1 site in United Kingdom.
Trial summary
This is a randomised trial of two modern single electric breast pumps allocated to mothers who are exclusively breast feeding their healthy term infants. Mothers will be recruited when their infants are around a month old, they will be randomised either to use one of two state of the art modern single electric breast… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Volume of Breast Milk Expressed Using Single Electric Breast Pumps., Duration of Exclusive Breast-feeding, Duration of Any Breast-feeding
- What is being tested?
- Electric breast pump - A and Electric breast pump - B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Aug 2016
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers who have delivered healthy, term, singleton infants with no contra-indications for successful breast feeding.
- Mothers who are exclusively breast feeding and are willing to be randomised to either use a breast pump or to continue breastfeeding without using a breast pump.
- Not already using a breast pump. Can speak, read and write in English (or Chinese for Beijing centre or Russian for Moscow centre)
Who cannot join
- Mothers are ineligible to join the study:
- If they are mixed or formula feeding. Have an illness that may prevent them from expressing breast milk. Are not willing to be randomly assigned to the pump or the control group Already expressing milk regularly.
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nutrition Unit, ICH-UCL
London, London, WC1N 1EH
Katherine Kennedy, MSc, 0044 20905 2256, k.kennedy@ucl.ac.uk
About this study
Official title: Randomised Trial Comparing the Efficacy and Acceptability of Two Single Electric Breast Pump in Mothers Exclusively Breast Feeding Their Healthy Term Infants.
This is a randomised trial of two modern single electric breast pumps allocated to mothers who are exclusively breast feeding their healthy term infants. Mothers will be recruited when their infants are around a month old, they will be randomised either to use one of two state of the art modern single electric breast pumps or to act as controls with no breast pump (but will receive a baby care voucher of similar value). If allocated to a breast pump, mothers will be asked to take part in a physiological study when their babies are 6 weeks old. In this test the mothers will be asked to express breast milk for 10 minutes on each breast. The primary hypothesis is that the total weight of milk produced in a 20 minute period and the weight of milk produced at 1 minute intervals at age 6 weeks will be greater for mothers using one of the pumps. A small sample of breast milk (~5ml) will be collected for analysis, the remaining expressed milk will returned to the mother.
Each month between the age of 3 and 6 months, all the mothers will be asked to complete online questionnaires about their breast-feeding and the use of their breast pumps (if they have one). At the end of the six months the mothers will be given a small voucher for a child-care store as a way of saying 'thank-you' for the inconvenience caused.
- Conditions
- Volume of Breast Milk Expressed Using Single Electric Breast Pumps., Duration of Exclusive Breast-feeding, Duration of Any Breast-feeding
- Being tested
- Electric breast pump - A, Electric breast pump - B
- Keywords
- Breast pumps, breast milk, expression, term infants
- 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.
Electric breast pump - ADevice
Also called Philips Avent single electric breast pump
Electric breast pump - BDevice
Also called Medela Swing single electric breast pump
| Study group | Role | What they receive |
|---|---|---|
| Primiparous mothers | Experimental | Mother who are primiparous Receives: Device: Electric breast pump - A; Device: Electric breast pump - B |
| Multiparous mothers | Experimental | Mothers who are multiparous Receives: Device: Electric breast pump - A; Device: Electric breast pump - B |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total weight of milk expressed in a set 20 minute period (10 minutes / breast)
The weight of milk expressed will be measured every minute for 20 minutes (10 mins/side) when the infants are around 5-6 weeks old.
Measured: up to 20 minutes
Secondary outcomes (1)
Exclusive and partial breast-feeding
Data will be collected at the end of each month when infants are 3 to 6 months of age to record if the infants are still being exclusively or partially breast-fed.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJun 2015
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume of Breast Milk Expressed Using Single Electric Breast Pumps.Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health, Scientific Center of Children, Capital Medical University
- Responsible party
- Sponsor
- Investigators
- Mary S Fewtrell, MD, Principal investigator, Institute of Child Health, UCL London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128295
- Sponsor's protocol ID
- 12NT04
- Other IDs
- UCL Ethics project ID 5645/001
- Status last verified
- Oct 2015
- First submitted
- 29 Apr 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing the Efficacy and Acceptability of Two Single Electric Breast Pump in Mothers Exclusively Breast Feeding Their Healthy Term Infants.
- ClinicalTrials.gov ID
- NCT02128295
- Acronym / sponsor ID
- 12NT04
- Conditions
- Volume of Breast Milk Expressed Using Single Electric Breast Pumps., Duration of Exclusive Breast-feeding, Duration of Any Breast-feeding
- Keywords
- Breast pumps, breast milk, expression, term infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Northwell Health, Scientific Center of Children, Capital Medical University
- Study start
- Jun 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 1 May 2014 (estimated)
- 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 a randomised trial of two modern single electric breast pumps allocated to mothers who are exclusively breast feeding their healthy term infants. Mothers will be recruited when their infants are around a month old, they will be randomised either to use one of two state of the art modern single electric breast pumps or to act as controls with no breast pump (but will receive a baby care voucher of similar value). If allocated to a breast pump, mothers will be asked to take part in a physiological study when their babies are 6 weeks old. In this test the mothers will be asked to express breast milk for 10 minutes on each breast. The primary hypothesis is that the total weight of milk produced in a 20 minute period and the weight of milk produced at 1 minute intervals at age 6 weeks will be greater for mothers using one of the pumps. A small sample of breast milk (~5ml) will be collected for analysis, the remaining expressed milk will returned to the mother.
Each month between the age of 3 and 6 months, all the mothers will be asked to complete online questionnaires about their breast-feeding and the use of their breast pumps (if they have one). At the end of the six months the mothers will be given a small voucher for a child-care store as a way of saying 'thank-you' for the inconvenience caused.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primiparous mothers | Experimental | Device: Electric breast pump - A, Device: Electric breast pump - BMother who are primiparous |
| Multiparous mothers | Experimental | Device: Electric breast pump - A, Device: Electric breast pump - BMothers who are multiparous |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mothers who have delivered healthy, term, singleton infants with no contra-indications for successful breast feeding.
- Mothers who are exclusively breast feeding and are willing to be randomised to either use a breast pump or to continue breastfeeding without using a breast pump.
- Not already using a breast pump. Can speak, read and write in English (or Chinese for Beijing centre or Russian for Moscow centre)
Key exclusion criteria (3 listed)
- If they are mixed or formula feeding. Have an illness that may prevent them from expressing breast milk. Are not willing to be randomly assigned to the pump or the control group Already expressing milk regularly.
- -
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 |
|---|---|---|
| Electric breast pump - AAlso: Philips Avent single electric breast pump | Device | Multiparous mothers, Primiparous mothers |
| Electric breast pump - BAlso: Medela Swing single electric breast pump | Device | Multiparous mothers, Primiparous mothers |
Primary outcome
The total weight of milk expressed in a set 20 minute period (10 minutes / breast)
Time frame: up to 20 minutes
The weight of milk expressed will be measured every minute for 20 minutes (10 mins/side) when the infants are around 5-6 weeks old.
1 secondary outcome
Exclusive and partial breast-feeding
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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.
Mary S Fewtrell, MD principal investigator
Institute of Child Health, UCL London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric breast pump - A and Electric breast pump - B in people with Volume of Breast Milk Expressed Using Single Electric Breast Pumps. and Duration of Exclusive Breast-feeding, run by University College, London at 1 site in United Kingdom.
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 3 inclusion and 3 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 3 Dec 2015. 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 Kingdom. 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 Mary Fewtrell (020 7905 2389, m.fewtrell@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total weight of milk expressed in a set 20 minute period (10 minutes / breast) (time frame: up to 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 3 Dec 2015.