Randomised Trial Comparing the Efficacy of the ISIS Duo iQ Electric Breast Pump and the Medela Symphony Electric Breast Pump in Mothers Expressing Breast Milk for Preterm Infants

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

Sponsors

Lead sponsor: Institute of Child Health

Source 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

Overall Status Unknown status
Start Date February 2009
Completion Date February 2010
Primary Completion Date July 2009
Study Type Observational
Primary Outcome
Measure Time Frame
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
Time taken for first milk to appear. 10 days post-partum
Secondary Outcome
Measure Time Frame
Total number of pumping sessions to Day 10. 10 days
Total time spent expressing to Day 10. 10 days
Mothers' opinions of the assigned pumps on Day 10. 1 day
Volume of milk expressed whilst on neonatal unit. 10 days
Number of days taken to reach full enteral feeds. 10 or more days
Enrollment 176
Condition
Eligibility

Sampling method: Probability Sample

Criteria:

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.

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Overall Contact

Last name: Pat Burton

Email: [email protected]

Location
facility status contact investigator Institute of Child Health, 30 Guilford Street Mary Fewtrell [email protected] Mary Fewtrell, Dr Principal Investigator
Location Countries

United Kingdom

Verification Date

April 2009

Responsible Party

Name title: Dr Mary Fewtrell

Organization: Institute of Child Health

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Electric Pump 1 (ISIS Duo iQ Electric Breast Pump)

Description: This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk. The use of electric breast pumps is routine practice on neonatal units in the UK.

Arm group label: Electric Pump 2 (Medela Symphony Electric Breast Pump)

Description: This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk. The use of electric breast pumps is routine practice on neonatal units in the UK.

Study Design Info

Observational model: Case Control

Time perspective: Prospective

Source: ClinicalTrials.gov