Levels of Contaminants in Human Milk | NCT01848444

Studies
Levels of Contaminants in Human Milk

NCT01848444

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Oct 9, 2015Estimated

Enrollment

187Actual

Phase

Not provided

Conditions

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

Interventions

Breastmilk

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CRC12014	Other Identifier	Assistance publique

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Apr 18, 2013

First Submission Date that Met QC Criteria

May 6, 2013

First Posted Date

May 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2015

Last Update Posted Date

Oct 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

187Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Breastmilk	Other	to measure levels of contaminants in human breastmilk samples	Lactating women who give her breastmilk to a milkbank

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Lactating women given their milk to a milk bank

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Virginie Rigourd, MD, PhD	Assistance Publique	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Necker		Paris			France