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

NCT ID: NCT00887991

Last Updated: 2009-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Milk Production

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Child Health

OTHER

Sponsor Role lead

Responsible Party

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Institute of Child Health

Principal Investigators

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Mary Fewtrell, Dr

Role: PRINCIPAL_INVESTIGATOR

Institute of Child Health

Pat Burton

Role: STUDY_DIRECTOR

Institute of Child Health

Locations

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Institute of Child Health, 30 Guilford Street

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Pat Burton

Role: CONTACT

Facility Contacts

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Mary Fewtrell

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 11389245 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26936878 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23776081 (View on PubMed)

Other Identifiers

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09NT02

Identifier Type: -

Identifier Source: org_study_id

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