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

March 27, 2016 updated by: Tel-Aviv Sourasky Medical Center

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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:

  1. 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.
  2. 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Department of Neonatology Tel Aviv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mothers of Preterms

Exclusion Criteria:

  • HIV infected mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electric Pump Modality
Each mother follows all 3 electric pump modalities in a randomized order.
Procedure: milk expression with electric pump
Other Names:
  • Medella Electric breast pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily volume of expressed breast milk under a specific electric pumping modality
Time Frame: after 15 minutes of electric expression of each breast
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
Time Frame: after the first morning session of electric milk expression
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Shaul Dollberg, MD, Tel Aviv Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 27, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-13-SD-0678-12-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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