Duration of Any Breast-feeding Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science