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

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.

Study Overview

• Status: Completed
• Conditions: Pollution; Exposure; Newborn; Microbiota; Breast Milk; Meconium; Pesticide; Stool
• Intervention / Treatment: Biological: breast milk collection; Biological: meconium collection; Biological: newborn feces collection; Other: questionary of pesticide exposure of the mother

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

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 mother-child pairs will be included in this project Newborn were born before 33 weeks of amenorrhea or at term born at least 37 weeks of amenorrhea.

mother are aged of 18 to 42 years old at the time of inclusion

Description

Inclusion Criteria:

• newborn born before 33 weeks of amenorrhea or at term born at least 37 weeks of amenorrhea
• mother aged of 18 to 42 years old at the time of inclusion
• mother not deprived of parental rights
• signed concerned consent
• mother having lived for at least 6 months in the Picardie subregion

Exclusion Criteria:

• newborn whose term of birth is between 33 and 37 weeks of amenorrhea
• mother minor or aged over 42 years
• mother deprived of her parental rights

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure of quantity of pesticides in mother's milk	the evaluation of the contamination of the mother's milk by pesticides will be done on 20 ml sample of breast milk.	between day 0 and day 4 after childbirth
measure of quantity of pesticides in mother's milk	the evaluation of the contamination of the mother's milk by pesticides will be done on 20 ml sample of breast milk.	between day 7 and day 15 after childbirth
measure of quantity of pesticides in mother's milk	the evaluation of the contamination of the mother's milk by pesticides will be done on 20 ml sample of breast milk.	between day 21 and day 30 after childbirth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between measure of quantity of pesticides in mother's milk and microbiota composition in mother's milk	correlation between pesticides contamination of mother's milk and microbiota composition in mother's milk	between day 0 and day 4 after childbirth
correlation between measure of quantity of pesticides in mother's milk and microbiota composition in mother's milk	correlation between pesticides contamination of mother's milk and microbiota composition in mother's milk	between day 7 and day 15 after childbirth
correlation between measure of quantity of pesticides in mother's milk and microbiota composition in mother's milk	correlation between pesticides contamination of mother's milk and microbiota composition in mother's milk	between day 21 and day 30 after childbirth

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: newborn; microbiota; breast milk; pesticide exposure; stool; meconium; persistent organic pollutants
• Other Study ID Numbers: PI2017_843_0032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No