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

Randomised Trial Comparing the Efficacy and Acceptability of Two Single Electric Breast Pump in Mothers Exclusively Breast Feeding Their Healthy Term Infants.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02128295

Enrollment

228

Registered

2014-05-01

Start date

2015-06-30

Completion date

2016-08-31

Last updated

2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Breast pumps, breast milk, expression, term infants

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.

Interventions

DEVICEElectric breast pump - A

DEVICEElectric breast pump - B

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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. \-

Design outcomes

Primary

Measure	Time frame	Description
The total weight of milk expressed in a set 20 minute period (10 minutes / breast)	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

Measure	Time frame	Description
Exclusive and partial breast-feeding	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.

Countries

United Kingdom

Contacts

Primary ContactMary Fewtrell

m.fewtrell@ucl.ac.uk020 7905 2389

Backup ContactKathy Kennedy

k.kennedy@ucl.ac.uk020 7905 2256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026