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

Completed

• Conditions: Premature Infants

• Registration Number: NCT02785926
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-24
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Primary Completion: 2018-10-22
• Study Completion: 2018-10-22
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response to hypoxia test (i.e peripheral chemoreceptor activity) in exposed and no exposed premature infant	10 days

Secondary Outcome Measures

Name	Time	Method
sleep structure with EEG	10 weeks
arousal in response to hypoxic test	10 weeks
apnea frequency	10 weeks

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France