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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Institute of Child Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00887991
First received: April 23, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5. [ Time Frame: 10 days post-partum ] [ Designated as safety issue: No ]
  • Time taken to express a fixed volume of milk. [ Time Frame: 10 days post-partum ] [ Designated as safety issue: No ]
  • Time taken for first milk to appear. [ Time Frame: 10 days post-partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total number of pumping sessions to Day 10. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Total time spent expressing to Day 10. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Mothers' opinions of the assigned pumps on Day 10. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Volume of milk expressed whilst on neonatal unit. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Number of days taken to reach full enteral feeds. [ Time Frame: 10 or more days ] [ Designated as safety issue: No ]

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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Mary Fewtrell, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00887991     History of Changes
Other Study ID Numbers: 09NT02
Study First Received: April 23, 2009
Last Updated: April 23, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Child Health:
Randomised trial
breast pumps
efficacy
preterm
Mothers of preterm infants who plan to express milk for their infants.

ClinicalTrials.gov processed this record on July 26, 2014