Impact of Different Electric Pumping Modalities on Milk Volume Production in Mothers of Preterm Infants

Study Overview
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Brief Summary
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Initiating and sustaining breastfeeding are common challenges in neonatal units. It is known that hindmilk expressed at the end of the expression session has a higher fat content. Previous studies have shown that simultaneous pumping is more effective at producing milk than sequential pumping. However this approach is often felt uncomfortable by the mothers, and sequential pumping is preferred. The purpose of this study is to determine which modality of milk expression by electric pump is the most efficient and productive when sequential pumping is used.This is done by assessing the milk volume expressed per expression and its macronutrients content.

Detailed Description
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The study will last for 6 days. Each mother will express breast milk following two designed modalities in a random fashion, for two days each. The two designed modalities are: Complete pumping of one breast (first left) for 15 min, followed by complete pumping of the right breast for 15 min, until the breast is empty. Pumping both breast simultaneously for 15 min. At day one of the study, the mothers will follow the standard pumping modality in practice at our department. In between the two studied procedures at day 4 of the study, the mothers will again follow the standard pumping modality. On each day of the study, in the morning after the first expression of the day, a sample of 2 ml of pumped breastmilk will be taken, and the total volume of the daily expressed milk will be recorded.

Official Title
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Milk Volume Production in Mothers of Preterm Infants: Electric Pumping Modalities

Conditions
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Prematurity

Intervention / Treatment
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* Procedure: milk expression with electric pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mothers of Preterms Exclusion Criteria: HIV infected mothers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electric Pump Modality<br>Each mother follows all 3 electric pump modalities in a randomized order. | Procedure: milk expression with electric pump<br> <br> * Other names: Medella Electric breast pump;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily volume of expressed breast milk under a specific electric pumping modality | The total volume of all milk expression sessions of the day will be recorded. This, for each 6 days of the study. | after 15 minutes of electric expression of each breast | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition of expressed milk under a specific electric pumping modality | Fat, Protein and Carbohydrate concentrations will be assessed after each morning session of milk expression by using the mid-infrared milk analyzer (Miris AB, Uppsala, Sweden) | after the first morning session of electric milk expression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mothers of Preterms, Breastfeeding Mothers of Preterm infants, mother milk feeding