Assessment of Autonomic Nervous Regulation During Postnatal Period in Newborns

NCT03830424 | Unknown

• 1 other identifier: EK69/2018
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn

Outcome Measures

Primary Outcomes (5)

• Characteristics of parasympathetic (vagal) heart regulation in newborns in relation to nociception

  The study of cardiac vagal regulation of heart rate in relation to nociceptive stimulus using conventional linear and novel nonlinear analysis of heart rate variability (HRV) by special software (Kubios HRV, University of Eastern Finland, Kuopio, Finland). Continual recordings of RR intervals will be recorded using Polar V800 (Polar, Finland). HRV indices: linear (time domain - mean square of successive differences (MSSD); spectral domain - low frequency power (LF), high frequency power (HF), total spectral power (TP); non-linear (symbolic dynamics - 0V%, 2LV%, entropy).

  within the first 4 days of postnatal life

• Characteristics of sympathetic activity in newborns in relation to nociception

  The study of sympathetic cholinergic system indexed by electrodermal activity (EDA) using linear and novel nonlinear parameters characterizing complex sympathetic behavior in relation to nociceptive stimulus. Continual EDA recording associated with peripheral temperature monitoring will be performed using device BioInfinity, Thought Technology Ltd., Canada. EDA indices: linear - SCA (skin conductance amplitude), frequency of NS-EDR (nonspecific electrodermal responses), nonlinear - SIE (symbolic information entropy), and ApEn (approximate entropy).

  within the first 4 days of postnatal life

• Autonomic (parasympathetic) reactivity in response to non-pharmacological pain relief in newborns

  The study of autonomic nervous system complex regulatory mechanisms included in the reactivity - test: stress stimulus (painful intervention) with non-pharmacological pain relieving and recovery phase using HRV quantitative and qualitative analysis. 1st group (control group, n=25) without pain relief; 2nd group (n=25) with oral application of sucrose during nociception stimulus; 3rd group (n=25) with oral application of mother milk during nociceptive stimulus.

  within the first 4 days of postnatal life - during and after pain stimulus

• Autonomic (sympathetic) reactivity in response to non-pharmacological pain relief in newborns

  The study of autonomic nervous system complex regulatory mechanisms included in the reactivity - test: stress stimulus (painful intervention) with non-pharmacological pain relieving and recovery phase using EDA quantitative and qualitative analysis. 1st group (control group, n=25) without pain relief; 2nd group (n=25) with oral application of sucrose during nociception stimulus; 3rd group (n=25) with oral application of mother milk during nociceptive stimulus.

  within the first 4 days of postnatal life - during and after pain stimulus

• Pain quality assessment in newborns: Neonatal Facial Coding System (NFCS) scaling system

  Assessment of the pain quality during painful intervention in newborns associated with muscular application of K vitamin after birth and heel lancing (blood spot) on 3rd postnatal day (standard neonatal care) according to Neonatal Facial Coding System (NFCS). NFCS: visual monitoring of newborn's face during pain stimulus for the presence of 9 specific facial actions: brow bulge, eye squeeze, naso - labial furrow, open lips, stretch mouth (horizontal/vertical), lip purse, taut tongue, chin quiver. Scale range: 0 - 9 points; (0 = no pain; 9 = maximal pain presentation).

  within the first 4 days of postnatal life - during pain stimulus

Secondary Outcomes (18)

• Developmental aspect of parasympathetic regulatory mechanisms in early postnatal period

  early after birth; 24 hours of life; 3rd - 4th day of life

• Developmental aspect of sympathetic regulatory mechanisms in early postnatal period

  early after birth; 24 hours of life; 3rd - 4th day of life

• Maternal clinical parameters effect on the neonatal autonomic (sympathetic) nervous system regulation

  prior to delivery + retrospective data

• Maternal clinical parameters effect on the neonatal autonomic (parasympathetic) nervous system regulation

  prior to delivery + retrospective data

• Delivery mode effect on autonomic (sympathetic) nervous system regulation

  at the time of delivery

Study Arms (3)

Control group

Healthy term newborns without pain relief during pain stimulus (intramuscular K vitamin administration and heel lancing for blood spot examination).

Procedure: Pain stimulus

Sucrose group

Healthy term newborns with oral application of sucrose during pain stimulus (intramuscular K vitamin administration and heel lancing for blood spot examination).

Procedure: Pain stimulus; Dietary Supplement: Non-pharmacological pain relief

Mother milk group

Healthy term newborns with oral application of mother milk during pain stimulus (intramuscular K vitamin administration and heel lancing for blood spot examination).

Procedure: Pain stimulus; Dietary Supplement: Non-pharmacological pain relief

Interventions

Pain stimulus PROCEDURE

Pain stimulus - intramuscular K vitamin administration, heel lancing = standard healthcare procedure

Control group; Mother milk group; Sucrose group

Non-pharmacological pain relief DIETARY_SUPPLEMENT

Administration of sucrose/mother milk during pain stimulus

Mother milk group; Sucrose group

Eligibility Criteria

• Age: 1 Hour - 4 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy term newborns with physiological postnatal adaptation born in University Hospital in Martin (Slovakia).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

Jessenius Medical Faculty, Comenius University

Martin, 03601, Slovakia

Location

Study Officials

• Mirko Zibolen, Prof, MD

  Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: February 5, 2019
• Study Start: February 15, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01

Locations

SL (1)