Levels of Contaminants in Human Milk (Conta-Lait)

Assistance Publique - Hôpitaux de Paris

Status: Completed

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

Treatments: Other: Breastmilk

Study type: Observational

Funder types: Other

Identifiers

NCT01848444

NI 12009

CRC12014 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

187 participants in 1 patient group

Lactating women who give her breastmilk to a milkbank

Description:

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

Treatment:

Other: Breastmilk