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

NCT03969459 | Completed

• 1 other identifier: PI2017_843_0032
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pesticide; Breast Milk; Pollution; Exposure; Meconium; Stool; Microbiota; Newborn

Keywords

pesticide exposure; persistent organic pollutants; breast milk; meconium; stool; microbiota; newborn

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• correlation between measure of quantity of pesticides in 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

  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

  between day 21 and day 30 after childbirth

Interventions

breast milk collection BIOLOGICAL

3 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.

meconium collection BIOLOGICAL

3 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.

newborn feces collection BIOLOGICAL

3 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.

questionary of pesticide exposure of the mother OTHER

maternal questionary of pesticide exposure of the mother

Eligibility Criteria

• Age: 1 Day - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• newborn born before 33 weeks of amenorrhea or at term born at least 37 weeks of amenorrhea
• mother not deprived of parental rights
• signed concerned consent
• mother having lived for at least 6 months in the Picardie subregion

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk for the mother, meconium and feces for the newborn

Study Officials

• Andre Leke, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 31, 2019
• Study Start: May 28, 2019
• Primary Completion: May 28, 2021
• Study Completion: February 28, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)