The Influence of Storage Container and Defrost Process on Components in Breast Milk

August 27, 2013 updated by: Taichung Veterans General Hospital
Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk. We investigate the influence of storage in different containers and different thawing or heating methods on human milk nutrients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

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

  • Taiwan
      • Taichung, Taiwan, 407
        • Division of Neonatology, Department of Pediatrics, Taichung Veterans General Hospital

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

healthy mothers lactating breast milk during first year of their babies

Description

Inclusion Criteria:

  • healthy mothers lactating during first year of their babies and have sufficient milk to donate

Exclusion Criteria:

  • mothers who have insufficient milk for their babies
  • mothers have major disease or on specific diet or drug which would affect breast milk composition

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in nutrients of human milk after several processing
Time Frame: within first year of milk expression
we measure the changes of nutrients, including fat, protein, lactose, energy, immunoglobulins, lactoferrin, leptin, and lysozyme in human milk after several processes, such as freezing, pasteurization, storage in different containers, thawing, and heat treatments.
within first year of milk expression

Collaborators and Investigators

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

Sponsor

Taichung Veterans General Hospital

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

January 1, 2009

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Estimate)

August 30, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • C08178

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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