Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451607
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2007-03-22
Brief Title:
Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in Premature Population
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Evaluation of Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in a Premature Population a Prospective Study
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None