Assessment of Autonomic Nervous Regulation During Postnatal Period in Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-15

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infant, Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

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

Pain stimulus

Intervention Type PROCEDURE

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

Sucrose group

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

Pain stimulus

Intervention Type PROCEDURE

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

Non-pharmacological pain relief

Intervention Type DIETARY_SUPPLEMENT

Administration of sucrose/mother milk during pain stimulus

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).

Pain stimulus

Intervention Type PROCEDURE

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

Non-pharmacological pain relief

Intervention Type DIETARY_SUPPLEMENT

Administration of sucrose/mother milk during pain stimulus

Interventions

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Pain stimulus

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

Intervention Type PROCEDURE

Non-pharmacological pain relief

Administration of sucrose/mother milk during pain stimulus

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Hour

Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes