Impact of Different Electric Pumping Modalities on Milk Volume Production in Mothers of Preterm Infants
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Milk Volume Production in Mothers of Preterm Infants: Electric Pumping Modalities|
- Daily volume of expressed breast milk under a specific electric pumping modality [ Time Frame: after 15 minutes of electric expression of each breast ] [ Designated as safety issue: No ]The total volume of all milk expression sessions of the day will be recorded. This, for each 6 days of the study.
- Composition of expressed milk under a specific electric pumping modality [ Time Frame: after the first morning session of electric milk expression ] [ Designated as safety issue: No ]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)
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Electric Pump Modality
Each mother follows all 3 electric pump modalities in a randomized order.
Procedure: milk expression with electric pump
Other Name: Medella Electric breast pump
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802047
|Contact: Shaul Dollberg, MDfirstname.lastname@example.org|
|Department of Neonatology Tel Aviv Medical Center||Not yet recruiting|
|Tel Aviv, Israel, 64239|
|Principal Investigator:||Shaul Dollberg, MD||Tel Aviv Medical Center|