Levels of Contaminants in Human Milk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-05-31

Brief Summary

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Recent international data have shown that the levels of chemical substances found in human milk could be at risk for breastfed infants. New data are necessary to assess this risk among French newborns.

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Detailed Description

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The objective of this study is to assess levels of certain contaminants in breastmilk. Measurements will be made on breastmilk samples collected in Milk Bank but not suitable for infants due to bacteriological reasons. 6 Milk Banks well distributed on the French territory will be contacted to participate. 180 women will be included. Women who gave their milk and correspond to the inclusion criteria (in particular breastfeeding a child under 6 months at the time of the donation) will be contacted by the investigator by phone. They will be asked to fill in a written consent as well as a questionnaire on socio-demographic data, pregnancy related information and potential environmental exposures.

2 breastmilk samples of 50 mL will be sendsending to the lab for analysis and 2 samples of 50 mL will be collected.

Conditions

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Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lactating women who give her breastmilk to a milkbank

180 women will be included in 6 milk banks in France during 18 months

Breastmilk

Intervention Type OTHER

to measure levels of contaminants in human breastmilk samples

Interventions

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Breastmilk

to measure levels of contaminants in human breastmilk samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

For the samples:

* Not allowed to use for bacteriological reasons
* Breastmilk samples from lactating women between delivery and 6 months (+/- 1 month) of the infant

For the mothers:

* Age \> or = 18 years
* Lived on the French territory
* Well french writer and speaker
* Mother child couple in good health
* Non opposability

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No