Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Hugues Patural, Flori S, Pichot V, Franco P, Pladys P, Beuchée A, Montemitro E, Bat-Pitault F, Porcher-Guinet V, Gillioen B, Dauphinot V, Rapin S, Stagnara C, Roche F and Barthelemy JC
Background: While a dysfunction of the autonomic nervous system (ANS) determined from the cardio-respiratory rhythms in children may represent a key criteria in the physiopathology of possible neurodevelopmental disorders, the normal thresholds and profile of the ANS maturation during the two first years of life have not been established.
Method : The Autonomic Baby Evaluation (AuBE) study is a prospective observational prospective single-center cohort following a population of 302 consecutive term and preterm newborns.
The primary objective of the “AuBE” prospective cohort is to define the autonomic nervous system maturity profile obtained, during the two first years of life, by repeated polysomnography and 24-hour ECG recordings, with a time scale values for each autonomic indices of interest and the secondary objective is to determine, the potential influence of this autonomic profile, on sleep disorders and on cognitive development at the age of 3. Parental questionnaires on sleep quality of children and mood status of the mother are collected at birth and at 6, 12, 18 and 24 months (i.e. M0, M6, M12, M18 and M24). A psychometric status is measured at 3 years for all children.
Results: Study population was included between September 2009 and September 2011. During these two years, a cohort of 302 children was recruited, including 271 (89.7%) term, and 31 (10.3%) preterm newborns. After an initial polysomnography at birth (M0), Holter ECG recordings ECG Holter recordings were performed at M6, M12 M18 and M24. A temporal and frequency domain analysis of the heart rate variability is being performed on each recording.
Conclusion: The strength of this study, is based on the longitudinal organization of a large cohort of newborns (n=302) including physiological maturation of cardiorespiratory systems drive, together with the quantitative and qualitative analysis of sleep and neurological and psychomotor outcome.
The demonstration of such a link between autonomic disorders in the neonatal period and the subsequent onset of sleep and/or psychomotor disorders 3 years later may improve the monitoring of neonates and help schedule early and adapted therapeutic interventions.