Breast Milk Content Expressed Manually Compared to Electric Pump

September 2, 2015 updated by: Tel-Aviv Sourasky Medical Center

Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive factors for the health and development of infants.Colostrum, which is produced in low quantities for the first 3 to 4 days after birth, is rich in immunologic components and developmental factors.

Breastfeeding difficulties during the first days of life of an infant are common. Moreover, not all infants can be directly fed at the breast.

Therefore, breast milk feeding at this early stage is initiated and promoted by the expression of breast milk either manually or by use of a pump. Whether the method of milk expression at this stage has a qualitative impact on colostrum is currently unknown.

The purpose of this randomized controlled study is to compare the effect of manual expression with electric pump expression upon the macronutrient composition of breast milk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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, Lis Maternity Hospital, 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:

  • Healthy lactating mothers of term infants

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Manual expression followed by electric pump
Mothers will be assigned to first express breast milk manually followed by electric pump
Procedure: Pump
Breast milk expression using manually or using an electric pump
EXPERIMENTAL: Electric pump followed by manual expression
Mothers will be assigned to first express breast milk by electric pump followed by manual expression
Procedure: Pump
Breast milk expression using manually or using an electric pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macronutrient content of expressed breast milk
Time Frame: 3 to 5 min
Mothers will express milk from the same breast indicated in the assigned arm. Macronutrient content will be analyzed using the Human Milk Analyzer
3 to 5 min

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 Dolberg, MD, Department of Pediatrics, Sakler Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2012

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (ESTIMATE)

February 19, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SD-0662-11-TLV

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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