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Levels of Contaminants in Human Milk

Evaluation of Different Chemical Substances in the Milk of Breastfed Infant

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01848444
Acronym
Conta-Lait
Enrollment
187
Registered
2013-05-07
Start date
2013-10-31
Completion date
2015-05-31
Last updated
2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Public Health, Epidemiology, Pharmacy Toxicology, Perinatal period

Brief summary

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

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.

Interventions

to measure levels of contaminants in human breastmilk samples

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)at the moment of the milk's donationanalysis of contaminants

Secondary

MeasureTime frameDescription
evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compoundsat the moment of the milk's donationanalysis of contaminants
To estimate the exposure of breastfed infants and to assess the risk in this populationat the moment of the milk's donationstatistical analysis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026