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Trial of Two Electric Breast Pumps in Mothers of Term Infants.

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ClinicalTrials.gov Identifier: NCT02128295
Recruitment Status : Unknown
Verified October 2015 by University College, London.
Recruitment status was:  Recruiting
First Posted : May 1, 2014
Last Update Posted : December 3, 2015
Sponsor:
Collaborators:
Northwell Health
Scientific Center of Children
Capital Medical University
Information provided by (Responsible Party):
University College, London

Brief 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 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.


Condition or disease Intervention/treatment Phase
Volume of Breast Milk Expressed Using Single Electric Breast Pumps. Duration of Exclusive Breast-feeding Duration of Any Breast-feeding Device: Electric breast pump - A Device: Electric breast pump - B Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Randomised Trial Comparing the Efficacy and Acceptability of Two Single Electric Breast Pump in Mothers Exclusively Breast Feeding Their Healthy Term Infants.
Study Start Date : June 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Primiparous mothers
Mother who are primiparous
Device: Electric breast pump - A
Other Name: Philips Avent single electric breast pump

Device: Electric breast pump - B
Other Name: Medela Swing single electric breast pump

Experimental: Multiparous mothers
Mothers who are multiparous
Device: Electric breast pump - A
Other Name: Philips Avent single electric breast pump

Device: Electric breast pump - B
Other Name: Medela Swing single electric breast pump




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Exclusive and partial breast-feeding [ Time Frame: up to 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128295


Contacts
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Contact: Mary Fewtrell 020 7905 2389 m.fewtrell@ucl.ac.uk
Contact: Kathy Kennedy 020 7905 2256 k.kennedy@ucl.ac.uk

Locations
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United Kingdom
Nutrition Unit, ICH-UCL Recruiting
London, United Kingdom, WC1N 1EH
Contact: Katherine Kennedy, MSc    0044 20905 2256    k.kennedy@ucl.ac.uk   
Sponsors and Collaborators
University College, London
Northwell Health
Scientific Center of Children
Capital Medical University
Investigators
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Principal Investigator: Mary S Fewtrell, MD Institute of Child Health, UCL London

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02128295     History of Changes
Other Study ID Numbers: 12NT04
UCL Ethics project ID 5645/001 ( Other Identifier: UCL Ethics )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: October 2015

Keywords provided by University College, London:
Breast pumps, breast milk, expression, term infants