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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Institute of Child Health.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00887991
First Posted: April 24, 2009
Last Update Posted: April 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute of Child Health
  Purpose
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

Condition
Milk Production

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • Total weight of milk expressed during the first 10 days post-partum. [ Time Frame: 10 days post-partum ]
  • Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5. [ Time Frame: 10 days post-partum ]
  • Time taken to express a fixed volume of milk. [ Time Frame: 10 days post-partum ]
  • Time taken for first milk to appear. [ Time Frame: 10 days post-partum ]

Secondary Outcome Measures:
  • Total number of pumping sessions to Day 10. [ Time Frame: 10 days ]
  • Total time spent expressing to Day 10. [ Time Frame: 10 days ]
  • Mothers' opinions of the assigned pumps on Day 10. [ Time Frame: 1 day ]
  • Volume of milk expressed whilst on neonatal unit. [ Time Frame: 10 days ]
  • Number of days taken to reach full enteral feeds. [ Time Frame: 10 or more days ]

Estimated Enrollment: 176
Study Start Date: February 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Electric Pump 1 (ISIS Duo iQ Electric Breast Pump)
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.
Electric Pump 2 (Medela Symphony Electric Breast Pump)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887991


Contacts
Contact: Pat Burton P.Burton@ich.ucl.ac.uk

Locations
United Kingdom
Institute of Child Health, 30 Guilford Street Recruiting
London, United Kingdom, WC1N 1EH
Contact: Mary Fewtrell       m.fewtrell@ich.ucl.ac.uk   
Principal Investigator: Mary Fewtrell, Dr         
Sponsors and Collaborators
Institute of Child Health
Investigators
Principal Investigator: Mary Fewtrell, Dr Institute of Child Health
Study Director: Pat Burton Institute of Child Health
  More Information