Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in Premature Population - Full Text View

Purpose

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

Premature Birth

MedlinePlus related topics:

Noise Stress

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Evaluation of Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in a Premature Population : a Prospective Study

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	38
Study Start Date:	March 2007
Study Completion Date:	September 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 6 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

premature birth
hospitalized in the intensive care unit or in the neonatology unit or in the reanimation unit of the Pediatric Hospital of SAINT-ETIENNE

Exclusion Criteria:

arrhythmias
general anaesthesia three weeks before the records

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451607

Locations


France
	CHU de Saint-Etienne
	SAINT-ETIENNE, France, 42055

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators


Principal Investigator:	Hugues PATURAL, MD	CHU de Saint-Etienne

More Information

Publications:

Patural H, Barthelemy JC, Pichot V, Mazzocchi C, Teyssier G, Damon G, Roche F. Birth prematurity determines prolonged autonomic nervous system immaturity. Clin Auton Res. 2004 Dec;14(6):391-5.

Responsible Party:	Centre Hospitalier Universitaire de Saint Etienne ( Françoise LORCA )
Study ID Numbers:	SNA STRESS 07
First Received:	March 22, 2007
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00451607
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

premature

newborn

heart rate variability

individualized sensorimotor care

noise

Study placed in the following topic categories:

Pregnancy Complications

Obstetric Labor, Premature

Obstetric Labor Complications

Stress

Premature Birth

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Centre Hospitalier Universitaire de Saint Etienne
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00451607