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Assessment of Autonomic Nervous Regulation During Postnatal Period in Newborns

NCT03830424 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2022-01-04

No results posted yet for this study

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

Interventions

PROCEDURE

Pain stimulus

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

DIETARY_SUPPLEMENT

Non-pharmacological pain relief

Administration of sucrose/mother milk during pain stimulus

Sponsors & Collaborators

  • Comenius University

    lead OTHER

Principal Investigators

  • Mirko Zibolen, Prof, MD · Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin

Eligibility

Min Age
1 Hour
Max Age
4 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2022-10-01
Completion
2022-12-31

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03830424 on ClinicalTrials.gov