Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort (AUBE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00951860|
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : September 23, 2014
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 or disease||Intervention/treatment|
|Fullterm Birth Neonate Prematurity||Other: Autonomic Nervous System activity|
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.
- Describe the pattern, i.e. the cardiac autonomic maturation during the first two years of life in a cohort of newborns.
- 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 Type :||Observational|
|Actual Enrollment :||302 participants|
|Official Title:||Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort : the AuBE Study|
|Study Start Date :||September 2009|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
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
- 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. [ Time Frame: at birth and at 6, 12, 18 and 24 months ]
- 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). [ Time Frame: At 24 months ]
- Specific criteria of pregnancy [ Time Frame: at birth ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951860
|CHU de Saint-Etienne|
|Saint-etienne, France, 42055|
|Principal Investigator:||Hugues PATURAL, MD PhD||CHU de Saint-Etienne|