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NCT01932619 Clinical Trial

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

Human Milk Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01932619
Other study ID # C08178
Secondary ID
Status Completed
Phase N/A
First received August 21, 2013
Last updated August 27, 2013
Start date January 2009
Est. completion date April 2013

Study information
Verified date August 2013
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Division of Neonatology, Department of Pediatrics, Taichung Veterans General Hospital Taichung

Sponsors (1)
Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary changes in nutrients of human milk after several processing 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
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