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NCT02785926: PHYSIOMECO

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

Completed Last updated 14 July 2020
What this trial tests

trial in Premature Infants in 53 participants. Completed in 22 October 2018.

Timeline
24 September 2013
Primary endpoint
22 October 2018
22 October 2018

Quick facts

Lead sponsorCentre Hospitalier Universitaire, Amiens
StatusCompleted
Study typeOBSERVATIONAL
Enrollment53
Start date24 September 2013
Primary completion22 October 2018
Estimated completion22 October 2018
Sites1 location across France

Conditions studied

Sponsor

Centre Hospitalier Universitaire, Amiens

Who can join

Adults 26 Weeks to 7 Months, any sex, with Premature Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02785926.

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