NCT01848444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

1.6 years

First QC Date

April 18, 2013

Last Update Submit

October 8, 2015

Conditions

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

Keywords

Public HealthEpidemiologyPharmacy ToxicologyPerinatal period

Outcome Measures

Primary Outcomes (1)

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

    analysis of contaminants

    at the moment of the milk's donation

Secondary Outcomes (2)

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

    at the moment of the milk's donation

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

    at the moment of the milk's donation

Study Arms (1)

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

Interventions

BreastmilkOTHER

to measure levels of contaminants in human breastmilk samples

Lactating women who give her breastmilk to a milkbank

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lactating women given their milk to a milk bank

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Necker

Paris, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

Study Officials

  • Virginie Rigourd, MD, PhD

    Assistance Publique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2013

First Posted

May 7, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 9, 2015

Record last verified: 2015-10

Locations

FR(1)