Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in Premature Population

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

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premature Birth

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Hugues PATURAL, MD, CHU de Saint-Etienne

Publications and helpful links

General 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. doi: 10.1007/s10286-004-0216-9.
• Patural H, Pichot V, Jaziri F, Teyssier G, Gaspoz JM, Roche F, Barthelemy JC. Autonomic cardiac control of very preterm newborns: a prolonged dysfunction. Early Hum Dev. 2008 Oct;84(10):681-7. doi: 10.1016/j.earlhumdev.2008.04.010. Epub 2008 Jun 16.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: March 22, 2007
• First Submitted That Met QC Criteria: March 22, 2007
• First Posted (Estimate): March 23, 2007

Study Record Updates

• Last Update Posted (Estimate): June 11, 2009
• Last Update Submitted That Met QC Criteria: June 10, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: newborn; premature; heart rate variability; noise; individualized sensorimotor care
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: SNA STRESS 07