NCT01932619

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
Last Updated

August 30, 2013

Status Verified

August 1, 2013

Enrollment Period

4.2 years

First QC Date

August 21, 2013

Last Update Submit

August 27, 2013

Conditions

Human Milk

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy mothers lactating breast milk during first year of their babies

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Neonatology, Department of Pediatrics, Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

breast milk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 30, 2013

Study Start

January 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

August 30, 2013

Record last verified: 2013-08

Locations

TW(1)