Levels of Contaminants in Human Milk (Conta-Lait)
Evaluation of Different Chemical Substances in the Milk of Breastfed Infant
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Paris, Frankrig
- Hopital Necker
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)
Tidsramme: at the moment of the milk's donation
|
analysis of contaminants
|
at the moment of the milk's donation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compounds
Tidsramme: at the moment of the milk's donation
|
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
Tidsramme: at the moment of the milk's donation
|
statistical analysis
|
at the moment of the milk's donation
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Virginie Rigourd, MD, PhD, Assistance Publique
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NI 12009
- CRC12014 (Anden identifikator: Assistance publique)
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