Levels of Contaminants in Human Milk (Conta-Lait)
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.
Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the Study
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Different Chemical Substances in the Milk of Breastfed Infant|
- Presence of contaminants (PCB, dioxins, furans and brominated flame retardants) [ Time Frame: at the moment of the milk's donation ] [ Designated as safety issue: No ]analysis of contaminants
- evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compounds [ Time Frame: at the moment of the milk's donation ] [ Designated as safety issue: No ]analysis of contaminants
- To estimate the exposure of breastfed infants and to assess the risk in this population [ Time Frame: at the moment of the milk's donation ] [ Designated as safety issue: No ]statistical analysis
Biospecimen Retention: Samples Without DNA
4*200 ml of breastmilk homogenizated and frozen -18° Celsius in the milk bank
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Lactating women who give her breastmilk to a milkbank
180 women will be included in 6 milk banks in France during 18 months
to measure levels of contaminants in human breastmilk samples
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01848444
|Contact: Raphael Serreau, MD, PhDemail@example.com|
|Contact: Virginie Rigourd, MD, PhD firstname.lastname@example.org|
|Principal Investigator:||Virginie Rigourd, MD, PhD||Assistance Publique|