Levels of Contaminants in Human Milk (Conta-Lait)

Evaluation of Different Chemical Substances in the Milk of Breastfed Infant

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.

Study Overview

• Status: Completed
• Conditions: Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the Study
• Intervention / Treatment: Other: Breastmilk

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 Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hopital Necker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Lactating women given their milk to a milk bank

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lactating women who give her breastmilk to a milkbank; 180 women will be included in 6 milk banks in France during 18 months	Other: Breastmilk; to measure levels of contaminants in human breastmilk samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)	analysis of contaminants	at the moment of the milk's donation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compounds	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	statistical analysis	at the moment of the milk's donation

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Virginie Rigourd, MD, PhD, Assistance Publique

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: May 6, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): October 9, 2015
• Last Update Submitted That Met QC Criteria: October 8, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Epidemiology; Public Health; Perinatal period; Pharmacy Toxicology
• Other Study ID Numbers: NI 12009; CRC12014 (Other Identifier: Assistance publique)