Trials / Unknown
UnknownNCT02128295
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- Sponsor
- University College, London · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Electric breast pump - A | |
| DEVICE | Electric breast pump - B |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2016-05-01
- Completion
- 2016-08-01
- First posted
- 2014-05-01
- Last updated
- 2015-12-03
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02128295. Inclusion in this directory is not an endorsement.