Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in Premature Population
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|ClinicalTrials.gov Identifier: NCT00451607|
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : June 11, 2009
Autonomic nervous system (ANS) is an essential regulator for the homeostasis, circulatory and respiratory systems. Heart rate variability, under the dependence of the parasympathetic and orthosympathetic arms is a peripheral witness of its well functioning.
Activity ANS indices are technically measurable from the birth by non invasive cardiac monitoring: in given environmental conditions. According to the individualized care given to the baby, we can easily observe by frequential analysis, modifications of ANS level activity; If for a full-term newborn, the balance of ANS allows him to adapt its cardiac frequency to its internal and external environment (thermoregulation, baroreflex, sinus arrhythmia, awakening state) , the premature birth is at the origin of a prolonged defect of global ANS maturation, probably induced by external environmental and stress factors (pain, stimulations, aggressive noise and lights). This disrupted maturation profile in case of prematurity, was confirmed in two preliminary studies on premature babies reaching term for gestational age.
We hypothesis that adapted sensorimotor care could decrease this stress and optimize the ANS activity profile.
In a prospective study, by a non invasive real-time measure, we analyse impact of stress on ANS activity in a premature population, hospitalized in our neonatal intensive care units.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Evaluation of Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in a Premature Population : a Prospective Study|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||September 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451607
|CHU de Saint-Etienne|
|Saint-etienne, France, 42055|
|Principal Investigator:||Hugues PATURAL, MD||CHU de Saint-Etienne|