Clinical Trials Directory

Trials / Completed

CompletedNCT03969459

Impact of Exposure to Persistent Organic Pollutants During Pregnancy on the Composition of Breast Milk and Consequences on the Newborn

Status
Completed
Phase
Study type
Observational
Enrollment
88 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
1 Day – 1 Day
Healthy volunteers
Not accepted

Summary

Epidemiological studies link early exposure to persistent organic pollutants (POPs) with health consequences in the newborn. Experimental studies have shown the impact of POPs on the gut microbiota. This project aims to characterize the POPs content in breast milk in an exposed population and to evaluate the impact on breast milk composition and intestinal microbiota establishment in the newborn. The health consequences will be evaluated by the clinical follow-up of the newborn.

Detailed description

Picardie is a sub-region with a young population and a high birth rate. The highlighting and the characterization of a maternal exhibition and the newborn will make it possible to know the in utero and postnatal exposure to the pesticides, and if necessary, to implement measures of information and prevention adapted to limit it. The study of pesticide exposure in the periconceptional period, ante and postnatal is crucial because of the vulnerability of this period to the environment and its immediate consequences on the health of the child but also in the long term on the development of chronic pathologies in adulthood. This study will allow us to assess the impact of POPs on the installation of the intestinal microbiota of newborn. 100 mother-child pairs will be included in this project. Samples of 20 mL of breast milk, meconium and stool of newborns will be taken. Gas chromatography or liquid phase analyzes coupled with mass spectrometry will be carried out on breast milk to evaluate the content of persistent organic pollutants and to isolate them. An analysis of the chemical composition of each milk sample will be performed. A bacteriological study for the enumeration of the germs in the mother's milk on the one hand then in the meconium and the saddles of the new-born on the other part will be realized. The DNA of isolated and identified germs will be compared by molecular biology techniques to determine their identity or non-identity within the microbiota of breast milk, meconium and newborn stool. The impact of breast milk contamination by pesticides on the health of newborn will be studied

Conditions

Interventions

TypeNameDescription
BIOLOGICALbreast milk collection3 samples of 20 ml of breast milk will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth.
BIOLOGICALmeconium collection3 samples of 20 ml of meconium milk will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth.
BIOLOGICALnewborn feces collection3 samples of 20 ml of newborn feces will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth.
OTHERquestionary of pesticide exposure of the mothermaternal questionary of pesticide exposure of the mother

Timeline

Start date
2019-05-28
Primary completion
2021-05-28
Completion
2023-02-28
First posted
2019-05-31
Last updated
2023-03-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03969459. Inclusion in this directory is not an endorsement.