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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00887991

Enrollment

176

Registered

2009-04-24

Start date

2009-02-28

Completion date

2010-02-28

Last updated

2009-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Milk Production

Keywords

Randomised trial, breast pumps, efficacy, preterm, Mothers of preterm infants who plan to express milk for their infants.

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Measure	Time frame
Total number of pumping sessions to Day 10.	10 days
Number of days taken to reach full enteral feeds.	10 or more 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

Countries

United Kingdom

Contacts

Primary ContactPat Burton

P.Burton@ich.ucl.ac.uk

Outcome results