PHYSIOMECO: Impact of Antenatal Exposure to Pesticides on Neurophysiological Functions (Sleep, Respiration) of Preterm Neonates

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT02785926
Collaborator
(none)
53
1
60.9
0.9

Study Details

Study Description

Brief Summary

During pregnancy, the foetus is therefore chronically exposed to a large number of substances. A number of studies have started to emphasize the effects of this antenatal exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.). However, in addition to these morphological effects, pesticides may also induce various effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters involved in many nervous system regulation pathways in man. This is particularly the case for organophosphates, which act as acetylcholinesterase inhibitors. A previous study conducted by the coordinator of the project presented here demonstrated the presence of high levels of this type of pesticide in meconium (1st stool) in neonates born in Picardy. This inhibition of the enzyme metabolizing ACh could have an impact on neurophysiological functions mediated by this neurotransmitter. Sleep or respiratory control, vital functions of the neonate particularly in preterm neonates, could therefore be affected.

The PhysioMéco project is therefore designed to study the possible links between antenatal exposure to pesticides and modifications of respiratory control allowed by peripheral chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays in the meconium of neonates in combination with an exposure questionnaire to determine the sources of these pesticides. Sleep and respiratory control will be studied in these neonates nursed in incubators. Hypoxic test will be used in order to assess respiratory control involving the peripheral chemoreceptors.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    53 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Antenatal Exposure to Pesticides on Neurophysiological Functions (Sleep, Respiration) of Preterm Neonates
    Actual Study Start Date :
    Sep 24, 2013
    Actual Primary Completion Date :
    Oct 22, 2018
    Actual Study Completion Date :
    Oct 22, 2018

    Outcome Measures

    Primary Outcome Measures

    1. response to hypoxia test (i.e peripheral chemoreceptor activity) in exposed and no exposed premature infant [10 days]

    Secondary Outcome Measures

    1. arousal in response to hypoxic test [10 weeks]

    2. sleep structure with EEG [10 weeks]

    3. apnea frequency [10 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    26 Weeks to 7 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • premature neonates born at after 26 week of gestational age studied after 32 weeks, mothers living in Picardy and more than 18 years
    Exclusion Criteria:
    • neonates with neurological, respiratory and cardiac disorders or receiving treatments known to affect cardiorespiratory variables or sleep structure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Amiens France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    • Principal Investigator: André LEKE, MD, CHU Amiens

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT02785926
    Other Study ID Numbers:
    • PI2013_843_0018
    First Posted:
    May 30, 2016
    Last Update Posted:
    Jul 14, 2020
    Last Verified:
    Jul 1, 2020
    Keywords provided by Centre Hospitalier Universitaire, Amiens

    Study Results

    No Results Posted as of Jul 14, 2020