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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
Information provided by:

Study Description
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.

Condition or disease
Premature Birth

Study Design

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Primary Completion Date : June 2007
Study Completion Date : September 2007
Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature Birth

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Principal Investigator: Hugues PATURAL, MD CHU de Saint-Etienne
More Information

Responsible Party: Clément CAILLAUX, Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00451607     History of Changes
Other Study ID Numbers: SNA STRESS 07
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
heart rate variability
individualized sensorimotor care

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications