Clinical trial NCT00451607: Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in Premature Population
Official title: Evaluation of Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in a Premature Population : a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: premature
newborn
heart rate variability
individualized sensorimotor care
noise
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2007-03-23
Enrollment: 39
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature Birth

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Hugues PATURAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.