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

Study Overview
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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

Official Title
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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

Conditions
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Milk Production

Participation Criteria
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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. Exclusion Criteria: Other mothers not fitting inclusion criteria.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Electric Pump 1 (ISIS Duo iQ Electric Breast Pump)<br>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)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of pumping sessions to Day 10. |  | 10 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 | 
| Number of days taken to reach full enteral feeds. |  | 10 or more days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomised trial, breast pumps, efficacy, preterm, Mothers of preterm infants who plan to express milk for their infants.