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

December 2, 2015 updated by: University College, London

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Not Applicable

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

  • United Kingdom
      • London, United Kingdom, WC1N 1EH
        • Recruiting
        • Nutrition Unit, ICH-UCL
        • Contact:

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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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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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primiparous mothers
Mother who are primiparous
Device: Electric breast pump - A
Other Names:
  • Philips Avent single electric breast pump
Device: Electric breast pump - B
Other Names:
  • Medela Swing single electric breast pump
Experimental: Multiparous mothers
Mothers who are multiparous
Device: Electric breast pump - A
Other Names:
  • Philips Avent single electric breast pump
Device: Electric breast pump - B
Other Names:
  • Medela Swing single electric breast pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Northwell Health
Capital Medical University
Scientific Center of Children

Investigators

  • Principal Investigator: Mary S Fewtrell, MD, Institute of Child Health, UCL London

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

June 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12NT04
  • UCL Ethics project ID 5645/001 (Other Identifier: UCL Ethics)

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.

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