Clinical trial NCT00887991: A Trial Comparing Two Breast Pumps in Mothers Expressing Milk for Their Preterm Infants
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Milk Production
Keywords: Randomised trial
breast pumps
efficacy
preterm
Mothers of preterm infants who plan to express milk for their infants.
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2009-04-24
Enrollment: 176
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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


Eligibility 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.

Primary outcomes:
measure: Total weight of milk expressed during the first 10 days post-partum.
timeFrame: 10 days post-partum
measure: Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5.
timeFrame: 10 days post-partum
measure: Time taken to express a fixed volume of milk.
timeFrame: 10 days post-partum
measure: Time taken for first milk to appear.
timeFrame: 10 days post-partum
Secondary outcomes:
measure: Total number of pumping sessions to Day 10.
timeFrame: 10 days
measure: Total time spent expressing to Day 10.
timeFrame: 10 days
measure: Mothers' opinions of the assigned pumps on Day 10.
timeFrame: 1 day
measure: Volume of milk expressed whilst on neonatal unit.
timeFrame: 10 days
measure: Number of days taken to reach full enteral feeds.
timeFrame: 10 or more days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Child Health, 30 Guilford Street
Study officials:
affiliation: Institute of Child Health
name: Mary Fewtrell, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Child Health
name: Pat Burton
role: STUDY_DIRECTOR
References:
citation: Fewtrell MS, Lucas P, Collier S, Singhal A, Ahluwalia JS, Lucas A. Randomized trial comparing the efficacy of a novel manual breast pump with a standard electric breast pump in mothers who delivered preterm infants. Pediatrics. 2001 Jun;107(6):1291-7. doi: 10.1542/peds.107.6.1291.
citation: Fewtrell MS, Kennedy K, Ahluwalia JS, Nicholl R, Lucas A, Burton P. Predictors of expressed breast milk volume in mothers expressing milk for their preterm infant. Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F502-F506. doi: 10.1136/archdischild-2015-308321. Epub 2016 Mar 2.
citation: Burton P, Kennedy K, Ahluwalia JS, Nicholl R, Lucas A, Fewtrell MS. Randomized trial comparing the effectiveness of 2 electric breast pumps in the NICU. J Hum Lact. 2013 Aug;29(3):412-9. doi: 10.1177/0890334413490995. Epub 2013 Jun 17.