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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00325-52 | Other Identifier | AFSSAPS |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autonomic Nervous System activity | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Autonomic activity is represented by time-domain indices and frequency- domain indices, which reflect the short-term variability (parasympathetic branch) and medium term (ortho and parasympathetic branch) of the vegetative balance. | at birth and at 6, 12, 18 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| the Bayley Scales of Infant Development, developmental with 4 areas of evaluation (motor or postural, oculomotor coordination, language, social relations) to calculate the global and partial quotient Development (QD). | At 24 months | |
| Specific criteria of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Hugues PATURAL, MD PhD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18582690 | Background | Patural H, Teyssier G, Pichot V, Barthelemy JC. [Normal and changed heart rate maturation of the neonate]. Arch Pediatr. 2008 Jun;15(5):614-6. doi: 10.1016/S0929-693X(08)71851-7. No abstract available. French. | |
| 18556151 | Background | 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. |
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|
| at birth |
| 17556047 | Background | De Rogalski Landrot I, Roche F, Pichot V, Teyssier G, Gaspoz JM, Barthelemy JC, Patural H. Autonomic nervous system activity in premature and full-term infants from theoretical term to 7 years. Auton Neurosci. 2007 Oct 30;136(1-2):105-9. doi: 10.1016/j.autneu.2007.04.008. Epub 2007 Jun 7. |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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