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

Primary Purpose

Prematurity

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
milk expression with electric pump
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prematurity focused on measuring Mothers of Preterms, Breastfeeding Mothers of Preterm infants, mother milk feeding

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Mothers of Preterms

Exclusion Criteria:

  • HIV infected mothers

Sites / Locations

  • Department of Neonatology Tel Aviv Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electric Pump Modality

Arm Description

Each mother follows all 3 electric pump modalities in a randomized order.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
February 19, 2013
Last Updated
March 27, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01802047
Brief Title
Impact of Different Electric Pumping Modalities on Milk Volume Production in Mothers of Preterm Infants
Official Title
Milk Volume Production in Mothers of Preterm Infants: Electric Pumping Modalities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
d/t changes in routine modality of milk expression by electric pump.
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
Mothers of Preterms, Breastfeeding Mothers of Preterm infants, mother milk feeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electric Pump Modality
Arm Type
Experimental
Arm Description
Each mother follows all 3 electric pump modalities in a randomized order.
Intervention Type
Procedure
Intervention Name(s)
milk expression with electric pump
Other Intervention Name(s)
Medella Electric breast pump
Primary Outcome Measure Information:
Title
Daily volume of expressed breast milk under a specific electric pumping modality
Description
The total volume of all milk expression sessions of the day will be recorded. This, for each 6 days of the study.
Time Frame
after 15 minutes of electric expression of each breast
Secondary Outcome Measure Information:
Title
Composition of expressed milk under a specific electric pumping modality
Description
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)
Time Frame
after the first morning session of electric milk expression

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mothers of Preterms Exclusion Criteria: HIV infected mothers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaul Dollberg, MD
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

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

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