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OpenTrials
Completed

NCT Number: NCT01848444

Levels of Contaminants in Human Milk

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.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hopital Necker

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastmilk

Other

to measure levels of contaminants in human breastmilk samples

Primary outcomes

  1. Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)

    Time frame: at the moment of the milk's donation

    analysis of contaminants

Secondary outcomes

  1. evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compounds

    Time frame: at the moment of the milk's donation

    analysis of contaminants

  2. To estimate the exposure of breastfed infants and to assess the risk in this population

    Time frame: at the moment of the milk's donation

    statistical analysis

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Evaluation of Different Chemical Substances in the Milk of Breastfed Infant

Acronym: Conta-Lait

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 7, 2013
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.