Status:
COMPLETED
Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Fullterm Birth
Neonate
Eligibility:
All Genders
Up to 1 years
Brief Summary
The heart rate variability assessment of the sympathetic-parasympathetic balance is a strong analytical tool in the autonomic nervous system (ANS) physiology, at each end of life. In neonatology, it ...
Detailed Description
To meet this objective, we propose to describe for the first time in a cohort of newborns, the cardiac autonomic maturation profile in the first two years of life and the neurological evolution at 2 y...
Eligibility Criteria
Inclusion
- Every child born in the CHU of Saint-Étienne (inborn), any term of its birth, in the hospital neonatal unit at the time of registration (after 37 weeks corrected for prematurity) or in the maternity
- Written consent signed by parents
- Parents affiliated in a Social Security regimen
Exclusion
- History of intrafamilial dysautonomia
- Heart malformation, congenital abnormality of the brainstem
- Permanent troubles of heart rate
- Any therapy at the time of the study or made in the weeks preceding the study, referred to cardiac or respiratory or known to alter the activity of the ANS
- General anesthesia within 2 weeks prior to registration
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00951860
Start Date
September 1 2009
End Date
July 1 2014
Last Update
September 23 2014
Active Locations (1)
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1
CHU de Saint-Etienne
Saint-Etienne, France, 42055