A Trial Comparing Two Breast Pumps in Mothers Expressing Milk for Their Preterm Infants
April 23, 2009 updated by: Institute of Child Health
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
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
176
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, WC1N 1EH
- Recruiting
- Institute of Child Health, 30 Guilford Street
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Contact:
- Mary Fewtrell
- Email: m.fewtrell@ich.ucl.ac.uk
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Principal Investigator:
- Mary Fewtrell, Dr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Other mothers not fitting inclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Total weight of milk expressed during the first 10 days post-partum.
Time Frame: 10 days post-partum
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10 days post-partum
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Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5.
Time Frame: 10 days post-partum
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10 days post-partum
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Time taken to express a fixed volume of milk.
Time Frame: 10 days post-partum
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10 days post-partum
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Time taken for first milk to appear.
Time Frame: 10 days post-partum
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10 days post-partum
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Total number of pumping sessions to Day 10.
Time Frame: 10 days
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10 days
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Total time spent expressing to Day 10.
Time Frame: 10 days
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10 days
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Mothers' opinions of the assigned pumps on Day 10.
Time Frame: 1 day
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1 day
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Volume of milk expressed whilst on neonatal unit.
Time Frame: 10 days
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10 days
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Number of days taken to reach full enteral feeds.
Time Frame: 10 or more days
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10 or more days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary Fewtrell, Dr, Institute of Child Health
- Study Director: Pat Burton, Institute of Child Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Fewtrell 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.
- Burton 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Anticipated)
July 1, 2009
Study Completion (Anticipated)
February 1, 2010
Study Registration Dates
First Submitted
April 23, 2009
First Submitted That Met QC Criteria
April 23, 2009
First Posted (Estimate)
April 24, 2009
Study Record Updates
Last Update Posted (Estimate)
April 24, 2009
Last Update Submitted That Met QC Criteria
April 23, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09NT02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.