Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT00951860
Status:
COMPLETED
Last Update Posted:
2014-09-23
First Post:
2009-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Study Overview
Official Title:
Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort : the AuBE Study
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AUBE
Brief Summary:
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.
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.
Detailed Description:
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.
* Describe the pattern, i.e. the cardiac autonomic maturation during the first two years of life in a cohort of newborns.
Secondary objectives.
* Correlate in this cohort, the autonomous status at birth to the neurological psychomotor status at 2 years.
* Describe the autonomic pattern (evolution profile) during the first two years of life.
* According to specific criteria of pregnancy (maternal smoking, maternal hypertension and gestational age)
* According to data of morphometry (stature and weight development) at birth.
* According to the neonatal morbidity criteria: - bronchopulmonary dysplasia i.e. oxygen dependence at 36 weeks postnatal age, persistent ductus arterious, intra ventricular haemorrhage according to the Papille classification, periventricular leukomalacia, enterocolitis, nosocomial sepsis.
* According to the incidence of serious faintness and rhythmic disorders the two first years of life.
Main objective.
* Describe the pattern, i.e. the cardiac autonomic maturation during the first two years of life in a cohort of newborns.
Secondary objectives.
* Correlate in this cohort, the autonomous status at birth to the neurological psychomotor status at 2 years.
* Describe the autonomic pattern (evolution profile) during the first two years of life.
* According to specific criteria of pregnancy (maternal smoking, maternal hypertension and gestational age)
* According to data of morphometry (stature and weight development) at birth.
* According to the neonatal morbidity criteria: - bronchopulmonary dysplasia i.e. oxygen dependence at 36 weeks postnatal age, persistent ductus arterious, intra ventricular haemorrhage according to the Papille classification, periventricular leukomalacia, enterocolitis, nosocomial sepsis.
* According to the incidence of serious faintness and rhythmic disorders the two first years of life.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-A00325-52 | OTHER | AFSSAPS | View |