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

NCT ID: NCT00451607

Last Updated: 2009-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Birth

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Centre Hospitalier Universitaire de Saint Etienne

Principal Investigators

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Hugues PATURAL, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 15666067 (View on PubMed)

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.

Reference Type RESULT
PMID: 18556151 (View on PubMed)

Other Identifiers

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SNA STRESS 07

Identifier Type: -

Identifier Source: org_study_id

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