Levels of Contaminants in Human Milk

Completed

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

• Registration Number: NCT01848444
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-07
• Study Start: 2013-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 187

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lactating women who give her breastmilk to a milkbank	Breastmilk	180 women will be included in 6 milk banks in France during 18 months

Primary Outcome Measures

Name	Time	Method
Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)	at the moment of the milk's donation	analysis of contaminants

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Necker; 🇫🇷 Paris, France