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NCT Number: NCT00951860

Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort

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.

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Key information

Conditions

Fullterm Birth Female Urogenital Diseases and Pregnancy Complications Neonate Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prematurity Urogenital Diseases

Age range

Up to 1 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Written consent signed by parents
  • Parents affiliated in a Social Security regimen

Exclusion criteria

  • History of intrafamilial dysautonomia
  • Heart malformation, congenital abnormality of the brainstem
  • Permanent troubles of heart rate
  • Any therapy at the time of the study or made in the weeks preceding the study, referred to cardiac or respiratory or known to alter the activity of the ANS
  • General anesthesia within 2 weeks prior to registration

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Specific criteria of pregnancy

    Time frame: at birth

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort : the AuBE Study

Acronym: AUBE

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Aug 4, 2009
Registry last updated
Sep 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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