Clinical trial NCT03830424: Assessment of Autonomic Nervous Regulation During Postnatal Period in Newborns
Official title: Assessment of Autonomic Nervous System Regulatory Mechanisms During Postnatal Period in Newborns
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infant, Newborn
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy term newborns with physiological postnatal adaptation born in University Hospital in Martin (Slovakia).

Brief summary: The project aims to assess the regulatory mechanisms of autonomic nervous system using noninvasive methods in newborns during postnatal adaptation period. Evaluated parameters will include complex analysis of electrodermal activity as a parameter reflecting sympathetic cholinergic system and indices of heart rate variability reflecting the activity of parasympathetic cardiac regulation. The project is focused on the neuro-psycho-physiological characteristics of physiological adaptation in early postnatal age and the effect of non-pharmacological pain relieving.


Eligibility criteria: Inclusion Criteria:

* healthy term newborns
* physiological postnatal adaptation
* signed parental informed consent

Exclusion Criteria:

* preterm delivery
* impaired postnatal adaptation
* perinatal infection
* congenital diseases and genetic anomalies
* hypoglycemia
* hyperbilirubinemia requiring phototherapy treatment

Primary outcomes:
measure: Characteristics of parasympathetic (vagal) heart regulation in newborns in relation to nociception
timeFrame: within the first 4 days of postnatal life
measure: Characteristics of sympathetic activity in newborns in relation to nociception
timeFrame: within the first 4 days of postnatal life
measure: Autonomic (parasympathetic) reactivity in response to non-pharmacological pain relief in newborns
timeFrame: within the first 4 days of postnatal life - during and after pain stimulus
measure: Autonomic (sympathetic) reactivity in response to non-pharmacological pain relief in newborns
timeFrame: within the first 4 days of postnatal life - during and after pain stimulus
measure: Pain quality assessment in newborns: Neonatal Facial Coding System (NFCS) scaling system
timeFrame: within the first 4 days of postnatal life - during pain stimulus
Secondary outcomes:
measure: Developmental aspect of parasympathetic regulatory mechanisms in early postnatal period
timeFrame: early after birth; 24 hours of life; 3rd - 4th day of life
measure: Developmental aspect of sympathetic regulatory mechanisms in early postnatal period
timeFrame: early after birth; 24 hours of life; 3rd - 4th day of life
measure: Maternal clinical parameters effect on the neonatal autonomic (sympathetic) nervous system regulation
timeFrame: prior to delivery + retrospective data
measure: Maternal clinical parameters effect on the neonatal autonomic (parasympathetic) nervous system regulation
timeFrame: prior to delivery + retrospective data
measure: Delivery mode effect on autonomic (sympathetic) nervous system regulation
timeFrame: at the time of delivery
measure: Delivery mode effect on autonomic (parasympathetic) nervous system regulation
timeFrame: at the time of delivery
measure: Blood pressure in relation to autonomic (sympathetic) nervous system regulation
timeFrame: within the first 4 days of postnatal life
measure: Blood pressure in relation to autonomic (parasympathetic) nervous system regulation
timeFrame: within the first 4 days of postnatal life
measure: Blood oxygen saturation in relation to autonomic (sympathetic) nervous system regulation
timeFrame: within the first 4 days of postnatal life
measure: Blood oxygen saturation in relation to autonomic (parasympathetic) nervous system regulation
timeFrame: within the first 4 days of postnatal life
measure: Selected laboratory parameters in relation to autonomic (sympathetic) nervous system regulation
timeFrame: immediately after birth + on 3rd - 4th postnatal day
measure: Selected laboratory parameters in relation to autonomic (parasympathetic) nervous system regulation
timeFrame: immediately after birth + on 3rd - 4th postnatal day
measure: Acid - base parameters in relation to autonomic (sympathetic) nervous system regulation
timeFrame: immediately after birth + on 3rd - 4th postnatal day
measure: Acid - base parameters in relation to autonomic (parasympathetic) nervous system regulation
timeFrame: immediately after birth + on 3rd - 4th postnatal day
measure: Role of psychosocial factors in autonomic (sympathetic) nervous system regulation
timeFrame: immediately after birth + within the first 4 days of postnatal life
measure: Role of psychosocial factors in autonomic (parasympathetic) nervous system regulation
timeFrame: immediately after birth + within the first 4 days of postnatal life
measure: Role of umbilical cord clamping in autonomic (sympathetic) nervous system regulation
timeFrame: at the time of delivery
measure: Role of umbilical cord clamping in autonomic (parasympathetic) nervous system regulation
timeFrame: at the time of delivery
Other outcomes:
Locations:
city: Martin
country: Slovakia
facility: Jessenius Medical Faculty, Comenius University
Study officials:
affiliation: Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin
name: Mirko Zibolen, Prof, MD
role: STUDY_DIRECTOR
References: