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

NCT ID: NCT02128295

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Volume of Breast Milk Expressed Using Single Electric Breast Pumps. Duration of Exclusive Breast-feeding Duration of Any Breast-feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Primiparous mothers

Mother who are primiparous

Group Type EXPERIMENTAL

Electric breast pump - A

Intervention Type DEVICE

Electric breast pump - B

Intervention Type DEVICE

Multiparous mothers

Mothers who are multiparous

Group Type EXPERIMENTAL

Electric breast pump - A

Intervention Type DEVICE

Electric breast pump - B

Intervention Type DEVICE

Interventions

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Electric breast pump - A

Intervention Type DEVICE

Electric breast pump - B

Intervention Type DEVICE

Other Intervention Names

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Philips Avent single electric breast pump Medela Swing single electric breast pump

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northwell Health

OTHER

Sponsor Role collaborator

Scientific Center of Children

UNKNOWN

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary S Fewtrell, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Child Health, UCL London

Locations

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Nutrition Unit, ICH-UCL

London, London, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Mary Fewtrell

Role: CONTACT

020 7905 2389

Kathy Kennedy

Role: CONTACT

020 7905 2256

Facility Contacts

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Katherine Kennedy, MSc

Role: primary

0044 20905 2256

Other Identifiers

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UCL Ethics project ID 5645/001

Identifier Type: OTHER

Identifier Source: secondary_id

12NT04

Identifier Type: -

Identifier Source: org_study_id