Levels of Contaminants in Human Milk

Study Overview
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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.

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.

Official Title
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Evaluation of Different Chemical Substances in the Milk of Breastfed Infant

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

Intervention / Treatment
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* Other: Breastmilk


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lactating women who give her breastmilk to a milkbank<br>180 women will be included in 6 milk banks in France during 18 months | Other: Breastmilk<br>* to measure levels of contaminants in human breastmilk samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of contaminants (PCB, dioxins, furans and brominated flame retardants) | analysis of contaminants | at the moment of the milk's donation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compounds | analysis of contaminants | at the moment of the milk's donation | 
| To estimate the exposure of breastfed infants and to assess the risk in this population | statistical analysis | at the moment of the milk's donation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Public Health, Epidemiology, Pharmacy Toxicology, Perinatal period