A Trial Comparing Two Breast Pumps in Mothers Expressing Milk for Their Preterm Infants

• Conditions: Milk Production

• Registration Number: NCT00887991
• Lead Sponsor: Institute of Child Health

Brief Summary

This is a randomised controlled trial investigating the performance of two, 'state of the art' electric breast pumps in mothers who have delivered preterm infants. The main data collection period will be up to day 10 post delivery data. Data collected will include a record of the weight of milk produced during the first 10 days and a short questionnaire to find the mothers' opinions of the pumps used. On Day 5 a timed and weighed expression of 15 minutes will be carried out. After the first 10 days, mothers will be asked to collect brief information on their continuing use of their pumps and subsequent duration of breast and bottle feeding, mothers will be contacted at 3 and 6 months post-term

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Status Verified: 2009-04
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Last Update Submitted: 2009-04-23
• Study First Posted: 2009-04-24
• Last Update Posted: 2009-04-24
• Primary Completion: 2009-07
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 176

Inclusion Criteria

• Mothers who have delivered, preterm (before 34 weeks) infants who plan to express breast milk for their infant(s). Their infants will need to be less than 72 hours old prior to enrolment and likely to remain in NICUs for at least 10 days.

Exclusion Criteria

• Other mothers not fitting inclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time taken for first milk to appear.	10 days post-partum
Total weight of milk expressed during the first 10 days post-partum.	10 days post-partum
Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5.	10 days post-partum
Time taken to express a fixed volume of milk.	10 days post-partum

Secondary Outcome Measures

Name	Time	Method
Volume of milk expressed whilst on neonatal unit.	10 days
Mothers' opinions of the assigned pumps on Day 10.	1 day
Total number of pumping sessions to Day 10.	10 days
Total time spent expressing to Day 10.	10 days
Number of days taken to reach full enteral feeds.	10 or more days

Trial Locations

Locations (1)

Institute of Child Health, 30 Guilford Street; 🇬🇧 London, United Kingdom