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

NCT02128295 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2015-12-03

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Electric breast pump - A

DEVICE

Electric breast pump - B

Sponsors & Collaborators

  • Northwell Health

    collaborator OTHER

  • Scientific Center of Children

    collaborator UNKNOWN

  • Capital Medical University

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • Mary S Fewtrell, MD · Institute of Child Health, UCL London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-05-31
Completion
2016-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02128295 on ClinicalTrials.gov