Levels of Contaminants in Human Milk (Conta-Lait)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01848444
First received: April 18, 2013
Last updated: February 26, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    statistical analysis


Biospecimen Retention:   Samples Without DNA

4*200 ml of breastmilk homogenizated and frozen -18° Celsius in the milk bank


Estimated Enrollment: 180
Study Start Date: October 2013
Estimated Study Completion Date: November 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848444

Contacts
Contact: Raphael Serreau, MD, PhD 0033146239430 raphael.serreau@sat.aphp.fr

Locations
France
Hopital Necker Recruiting
Paris, France
Contact: Virginie Rigourd, MD, PhD       virginie.rigourd@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Virginie Rigourd, MD, PhD Assistance Publique
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01848444     History of Changes
Other Study ID Numbers: NI 12009, CRC12014
Study First Received: April 18, 2013
Last Updated: February 26, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: French Data Protection Authority

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

ClinicalTrials.gov processed this record on July 26, 2014