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CompletedNCT02785926PHYSIOMECOUpdated Jul 14, 2020

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

An observational study in Premature Infants, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 26 Weeks to 7 Months. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
53
Ages
26 Weeks to 7 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Premature Infants

Keywords

  • pesticide exposure
  • respiratory control
  • sleep
03

In context

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Weeks to 7 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

premature neonates

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

Exclusion Criteria:

  • neonates with neurological, respiratory and cardiac disorders or receiving treatments known to affect cardiorespiratory variables or sleep structure
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
53 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Time frame: 10 days

Secondary outcomes

  1. arousal in response to hypoxic test

    Time frame: 10 weeks

  2. sleep structure with EEG

    Time frame: 10 weeks

  3. apnea frequency

    Time frame: 10 weeks

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80054, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02785926
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
May 30, 2016
Start date
Sep 24, 2013
Primary completion
Oct 22, 2018
Completion
Oct 22, 2018
Last update
Jul 14, 2020

Study contacts

André LEKE, MD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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