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Completed

NCT Number: NCT02785926

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

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.

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Key information

Age range

26 week–7 month

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PHYSIOMECO

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 30, 2016
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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