Milk ProductionNCT00887991
A Trial Comparing Two Breast Pumps in Mothers Expressing Milk for Their Preterm Infants
An observational study of Milk Production, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
This is a randomised controlled trial investigating the performance of two, 'state of the art' electric breast pumps in mothers who have delivered preterm infants. The main data collection period will be up to day 10 post delivery data. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Milk Production
- How many people
- 176 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Feb 2010
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk.
Who may be able to join
- Mothers who have delivered, preterm (before 34 weeks) infants who plan to express breast milk for their infant(s). Their infants will need to be less than 72 hours old prior to enrolment and likely to remain in NICUs for at least 10 days.
Who cannot join
- Other mothers not fitting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Pat Burton contact
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Child Health, 30 Guilford Street
London, WC1N 1EH
Mary Fewtrell, m.fewtrell@ich.ucl.ac.uk
Mary Fewtrell, Dr
About this study
Official title: Randomised Trial Comparing the Efficacy of the ISIS Duo iQ Electric Breast Pump and the Medela Symphony Electric Breast Pump in Mothers Expressing Breast Milk for Preterm Infants
This is a randomised controlled trial investigating the performance of two, 'state of the art' electric breast pumps in mothers who have delivered preterm infants. The main data collection period will be up to day 10 post delivery data. Data collected will include a record of the weight of milk produced during the first 10 days and a short questionnaire to find the mothers' opinions of the pumps used. On Day 5 a timed and weighed expression of 15 minutes will be carried out. After the first 10 days, mothers will be asked to collect brief information on their continuing use of their pumps and subsequent duration of breast and bottle feeding, mothers will be contacted at 3 and 6 months post-term
- Conditions
- Milk Production
- Keywords
- Randomised trial, breast pumps, efficacy, preterm, Mothers of preterm infants who plan to express milk for their infants.
- Medical subject headings
- Breast Milk Expression, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Electric Pump 1 (ISIS Duo iQ Electric Breast Pump) | This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk. The use of electric breast pumps is routine practice on neonatal units in the UK. | |
| Electric Pump 2 (Medela Symphony Electric Breast Pump) | This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk. The use of electric breast pumps is routine practice on neonatal units in the UK. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total weight of milk expressed during the first 10 days post-partum.
Measured: 10 days post-partum
Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5.
Measured: 10 days post-partum
Time taken to express a fixed volume of milk.
Measured: 10 days post-partum
Time taken for first milk to appear.
Measured: 10 days post-partum
Secondary outcomes (5)
Total number of pumping sessions to Day 10.
Measured: 10 days
Total time spent expressing to Day 10.
Measured: 10 days
Mothers' opinions of the assigned pumps on Day 10.
Measured: 1 day
Volume of milk expressed whilst on neonatal unit.
Measured: 10 days
Number of days taken to reach full enteral feeds.
Measured: 10 or more days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Milk ProductionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Mary Fewtrell, Dr, Principal investigator, Institute of Child HealthPat Burton, Study director, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887991
- Sponsor's protocol ID
- 09NT02
- Status last verified
- Apr 2009
- First submitted
- 23 Apr 2009
- Last updated
- 24 Apr 2009
- Results posted
- No
Publications
Fewtrell MS, Lucas P, Collier S, Singhal A, Ahluwalia JS, Lucas A. Randomized trial comparing the efficacy of a novel manual breast pump with a standard electric breast pump in mothers who delivered preterm infants. Pediatrics. 2001 Jun;107(6):1291-7. doi: 10.1542/peds.107.6.1291.
PubMed 11389245Fewtrell MS, Kennedy K, Ahluwalia JS, Nicholl R, Lucas A, Burton P. Predictors of expressed breast milk volume in mothers expressing milk for their preterm infant. Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F502-F506. doi: 10.1136/archdischild-2015-308321. Epub 2016 Mar 2.
PubMed 26936878Burton P, Kennedy K, Ahluwalia JS, Nicholl R, Lucas A, Fewtrell MS. Randomized trial comparing the effectiveness of 2 electric breast pumps in the NICU. J Hum Lact. 2013 Aug;29(3):412-9. doi: 10.1177/0890334413490995. Epub 2013 Jun 17.
PubMed 23776081
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing the Efficacy of the ISIS Duo iQ Electric Breast Pump and the Medela Symphony Electric Breast Pump in Mothers Expressing Breast Milk for Preterm Infants
- ClinicalTrials.gov ID
- NCT00887991
- Acronym / sponsor ID
- 09NT02
- Conditions
- Milk Production
- Keywords
- Randomised trial, breast pumps, efficacy, preterm, Mothers of preterm infants who plan to express milk for their infants.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 24 Apr 2009 (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 controlled trial investigating the performance of two, 'state of the art' electric breast pumps in mothers who have delivered preterm infants. The main data collection period will be up to day 10 post delivery data. Data collected will include a record of the weight of milk produced during the first 10 days and a short questionnaire to find the mothers' opinions of the pumps used. On Day 5 a timed and weighed expression of 15 minutes will be carried out. After the first 10 days, mothers will be asked to collect brief information on their continuing use of their pumps and subsequent duration of breast and bottle feeding, mothers will be contacted at 3 and 6 months post-term
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric Pump 1 (ISIS Duo iQ Electric Breast Pump) | – | –This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk. The use of electric breast pumps is routine practice on neonatal units in the UK. |
| Electric Pump 2 (Medela Symphony Electric Breast Pump) | – | –This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk. The use of electric breast pumps is routine practice on neonatal units in the UK. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk.
Key inclusion criteria (1 listed)
- Mothers who have delivered, preterm (before 34 weeks) infants who plan to express breast milk for their infant(s). Their infants will need to be less than 72 hours old prior to enrolment and likely to remain in NICUs for at least 10 days.
Key exclusion criteria (1 listed)
- Other mothers not fitting inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total weight of milk expressed during the first 10 days post-partum.
Time frame: 10 days post-partum
Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5.
Time frame: 10 days post-partum
Time taken to express a fixed volume of milk.
Time frame: 10 days post-partum
Time taken for first milk to appear.
Time frame: 10 days post-partum
5 secondary outcomes
Total number of pumping sessions to Day 10.
Time frame: 10 days
Total time spent expressing to Day 10.
Time frame: 10 days
Mothers' opinions of the assigned pumps on Day 10.
Time frame: 1 day
Volume of milk expressed whilst on neonatal unit.
Time frame: 10 days
Number of days taken to reach full enteral feeds.
Time frame: 10 or more days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2009.
- Background: PubMed 11389245Fewtrell MS, Lucas P, Collier S, Singhal A, Ahluwalia JS, Lucas A. Randomized trial comparing the efficacy of a novel manual breast pump with a standard electric breast pump in mothers who delivered preterm infants. Pediatrics. 2001 Jun;107(6):1291-7. doi: 10.1542/peds.107.6.1291.
- Derived from this study: PubMed 26936878Fewtrell MS, Kennedy K, Ahluwalia JS, Nicholl R, Lucas A, Burton P. Predictors of expressed breast milk volume in mothers expressing milk for their preterm infant. Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F502-F506. doi: 10.1136/archdischild-2015-308321. Epub 2016 Mar 2.
- Derived from this study: PubMed 23776081Burton P, Kennedy K, Ahluwalia JS, Nicholl R, Lucas A, Fewtrell MS. Randomized trial comparing the effectiveness of 2 electric breast pumps in the NICU. J Hum Lact. 2013 Aug;29(3):412-9. doi: 10.1177/0890334413490995. Epub 2013 Jun 17.
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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.
Pat Burton contact
Mary Fewtrell, Dr principal investigator
Institute of Child Health
Pat Burton study director
Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Milk Production, run by Institute of Child Health 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 1 inclusion and 1 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 24 Apr 2009. 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 Pat Burton (P.Burton@ich.ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total weight of milk expressed during the first 10 days post-partum. (time frame: 10 days post-partum). The study lists 4 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 NCT00887991, which also lists 3 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 24 Apr 2009.