Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the StudyConta-LaitNCT01848444
Levels of Contaminants in Human Milk
An observational study of Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the Study, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the Study
- What is being tested?
- Breastmilk
- How many people
- 187 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Lactating women given their milk to a milk bank
Who may be able to join
- 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
Show all 9Show fewer
- Well french writer and speaker
- Mother child couple in good health
- Non opposability
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Chemical Substances in the Milk of Breastfed Infant
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.
Read the 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.
- Being tested
- Breastmilk
- Keywords
- Public Health, Epidemiology, Pharmacy Toxicology, Perinatal period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastmilkOther
to measure levels of contaminants in human breastmilk samples
| Study group | Role | What they receive |
|---|---|---|
| Lactating women who give her breastmilk to a milkbank | 180 women will be included in 6 milk banks in France during 18 months Receives: Other: Breastmilk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)
analysis of contaminants
Measured: at the moment of the milk's donation
Secondary outcomes (2)
evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compounds
analysis of contaminants
Measured: at the moment of the milk's donation
To estimate the exposure of breastfed infants and to assess the risk in this population
statistical analysis
Measured: at the moment of the milk's donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the StudyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie Rigourd, MD, PhD, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848444
- Sponsor's protocol ID
- NI 12009
- Other IDs
- CRC12014
- Acronym
- Conta-Lait
- Status last verified
- Oct 2015
- First submitted
- 18 Apr 2013
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Chemical Substances in the Milk of Breastfed Infant
- ClinicalTrials.gov ID
- NCT01848444
- Acronym / sponsor ID
- Conta-Lait / NI 12009
- Keywords
- Public Health, Epidemiology, Pharmacy Toxicology, Perinatal period
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactating women who give her breastmilk to a milkbank | – | Other: Breastmilk180 women will be included in 6 milk banks in France during 18 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lactating women given their milk to a milk bank
Key inclusion criteria (9 listed)
- Not allowed to use for bacteriological reasons
- Breastmilk samples from lactating women between delivery and 6 months (+/- 1 month) of the infant
- Age > or = 18 years
- Lived on the French territory
- Well french writer and speaker
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastmilkto measure levels of contaminants in human breastmilk samples | Other | Lactating women who give her breastmilk to a milkbank |
Primary outcome
Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)
Time frame: at the moment of the milk's donation
analysis of contaminants
2 secondary outcomes
evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compounds
Time frame: at the moment of the milk's donation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie Rigourd, MD, PhD principal investigator
Assistance Publique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the Study, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of contaminants (PCB, dioxins, furans and brominated flame retardants) (time frame: at the moment of the milk's donation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.