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| Sponsor: | Centre Hospitalier Universitaire de Saint Etienne |
|---|---|
| Collaborator: |
Ministry of Health, France |
| Information provided by: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT00951860 |
Purpose
The heart rate variability assessment of the sympathetic-parasympathetic balance is a strong analytical tool in the autonomic nervous system (ANS) physiology, at each end of life.
In neonatology, it represents an important marker for understanding the breath and cardiac dysfunction, incriminated in the pathophysiology of unexplained death syndrome and apnea-bradycardia of prematurity.
If recent clinical studies conducted by our team highlight a close link between the maturation degree of the ANS and gestational or postnatal age, with a substantial autonomic dysfunction in preterm infants, no study to date has focused profile autonomic maturation in the first two years of life, as that period for the infant is a vulnerability "window" especially cardiopulmonary and neurological.
Psychomotor prognosis of newborns is more serious if prematurity is important and if periventricular leukomalacia or cortical anatomical brain lesions are obvious. However, the conventional imaging (Trans fontanel ultrasound, CT, MRI) is not sufficient in the neonatal period to thoroughly evaluate the neurological risk situations. During the neonatal period, the assessment of autonomic control, in practice easily quantifiable from time and frequency-domain analysis of cardiac RR variability, could be a strong marker, at a given time, from a neurological disorder undetectable by imaging, including sympathetic and parasympathetic nerve conduction dysfunction in some brainstem nuclei and cortical areas.
The postnatal profile of the autonomic balance, as a marker of well ANS regulation could become an additional support to correlate transient or permanent autonomic deficit with a psychomotor development disorder at 2 years of age or later. This tool could be a help to target the children with a neurological risk and to schedule early therapeutic interventions and psychological or educational support.
| Condition | Intervention |
|---|---|
|
Fullterm Birth Neonate Prematurity |
Other: Autonomic Nervous System activity |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort : the AuBE Study |
| Estimated Enrollment: | 800 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Newborn
Every child born in the CHU of Saint-Étienne (inborn), any term of its birth, in the hospital neonatal unit at the time of registration (after 37 weeks corrected for prematurity) or in the maternity
|
Other: Autonomic Nervous System activity
Autonomic activity measured at birth and at 6, 12, 18 and 24 months is represented by time-domain indices (SDNN index, SDANN, pNN50) and frequency- domain indices(PTOT, VLF, LF, HF, ratio LF / HF, LFnu, HFnu), which reflect the short-term variability (parasympathetic branch) and medium term (ortho and parasympathetic branch) of the vegetative balance. This subtle technical assessment of autonomic functioning has been validated in the literature for two decades
|
To meet this objective, we propose to describe for the first time in a cohort of newborns, the cardiac autonomic maturation profile in the first two years of life and the neurological evolution at 2 years.
Main objective.
Secondary objectives.
Eligibility| Ages Eligible for Study: | up to 1 Week |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Every child born in the CHU of Saint-Étienne (inborn), any term of its birth, in the hospital neonatal unit at the time of registration (after 37 weeks corrected for prematurity) or in the maternity
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Hugues PATURAL, MD PhD | +33(0)477828542 | hugues.patural@chu-st-etienne.fr |
| Contact: Frederic ROCHE, MD-PhD | +33(0)477828300 | frederic.roche@univ-st-etienne.fr |
| France | |
| CHU de Saint-Etienne | Recruiting |
| Saint-etienne, France, 42055 | |
| Principal Investigator: Hugues PATURAL, MD PhD | |
| Sub-Investigator: Georges TEYSSIER, MD PhD | |
| Sub-Investigator: Kareen BILLIEMAZ, MD | |
| Sub-Investigator: Caroline PARICIO, MD | |
| Principal Investigator: | Hugues PATURAL, MD PhD | CHU de Saint-Etienne |
More Information
| Responsible Party: | Centre Hospitalier Universitaire de Saint-Etienne ( Clément CAILLAUX ) |
| Study ID Numbers: | 0908020, 2009-A00325-52 |
| Study First Received: | August 3, 2009 |
| Last Updated: | February 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00951860 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority |
|
Fullterm Birth Neonate Prematurity Neurodevelopment Autonomic Nervous System activity |