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Levels of Contaminants in Human Milk (Conta-Lait)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01848444
First Posted: May 7, 2013
Last Update Posted: October 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the Study Other: Breastmilk

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Different Chemical Substances in the Milk of Breastfed Infant

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Presence of contaminants (PCB, dioxins, furans and brominated flame retardants) [ Time Frame: at the moment of the milk's donation ]
    analysis of contaminants


Secondary Outcome Measures:
  • 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

  • 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


Biospecimen Retention:   Samples Without DNA
4*200 ml of breastmilk homogenizated and frozen -18° Celsius in the milk bank

Enrollment: 187
Study Start Date: October 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lactating women given their milk to a milk bank
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848444


Locations
France
Hopital Necker
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Virginie Rigourd, MD, PhD Assistance Publique
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01848444     History of Changes
Other Study ID Numbers: NI 12009
CRC12014 ( Other Identifier: Assistance publique )
First Submitted: April 18, 2013
First Posted: May 7, 2013
Last Update Posted: October 9, 2015
Last Verified: October 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Public Health
Epidemiology
Pharmacy Toxicology
Perinatal period