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Trial record 5 of 1611 for:    Slovakia

Assessment of Autonomic Nervous Regulation During Postnatal Period in Newborns

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ClinicalTrials.gov Identifier: NCT03830424
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Comenius University

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.

Condition or disease Intervention/treatment
Infant, Newborn Procedure: Pain stimulus Dietary Supplement: Non-pharmacological pain relief

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of Autonomic Nervous System Regulatory Mechanisms During Postnatal Period in Newborns
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
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
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).
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

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
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




Primary Outcome Measures :
  1. Characteristics of parasympathetic (vagal) heart regulation in newborns in relation to nociception [ Time Frame: within the first 4 days of postnatal life ]

    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).


  2. Characteristics of sympathetic activity in newborns in relation to nociception [ Time Frame: within the first 4 days of postnatal life ]

    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).


  3. Autonomic (parasympathetic) reactivity in response to non-pharmacological pain relief in newborns [ Time Frame: within the first 4 days of postnatal life - during and after pain stimulus ]

    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.


  4. Autonomic (sympathetic) reactivity in response to non-pharmacological pain relief in newborns [ Time Frame: within the first 4 days of postnatal life - during and after pain stimulus ]

    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.


  5. Pain quality assessment in newborns: Neonatal Facial Coding System (NFCS) scaling system [ Time Frame: within the first 4 days of postnatal life - during pain stimulus ]

    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).



Secondary Outcome Measures :
  1. Developmental aspect of parasympathetic regulatory mechanisms in early postnatal period [ Time Frame: early after birth; 24 hours of life; 3rd - 4th day of life ]
    Assessment of the developmental aspect of cardiac vagal regulation indexed by HRV indices in relation to postnatal age (measures of HRV: early after birth; 24 hours of life; 3rd - 4th day of life).

  2. Developmental aspect of sympathetic regulatory mechanisms in early postnatal period [ Time Frame: early after birth; 24 hours of life; 3rd - 4th day of life ]
    Assessment of the developmental aspect of sympathetic cholinergic regulation indexed by EDA complex analysis in relation to postnatal age (early after birth; 24 hours of life; 3rd - 4th day of life).

  3. Maternal clinical parameters effect on the neonatal autonomic (sympathetic) nervous system regulation [ Time Frame: prior to delivery + retrospective data ]
    Study of the selected maternal clinical parameters [age (years), weight gain during pregnancy (kilograms), heart rate (beats per minute), systolic and diastolic blood pressure (millimeters of mercury) before delivery] in the interaction with sympathetic regulatory mechanisms - indexed by EDA.

  4. Maternal clinical parameters effect on the neonatal autonomic (parasympathetic) nervous system regulation [ Time Frame: prior to delivery + retrospective data ]
    Study of the selected maternal clinical parameters [age (years), weight gain during pregnancy (kilograms), heart rate (beats per minute), systolic and diastolic blood pressure (millimeters of mercury) before delivery] in the interaction with parasympathetic regulatory mechanisms - indexed by HRV.

  5. Delivery mode effect on autonomic (sympathetic) nervous system regulation [ Time Frame: at the time of delivery ]
    Study of the effect of delivery mode on the function and maturation of autonomic (sympathetic) nervous regulatory mechanisms - indexed by EDA.

  6. Delivery mode effect on autonomic (parasympathetic) nervous system regulation [ Time Frame: at the time of delivery ]
    Study of the effect of delivery mode on the function and maturation of autonomic (parasympathetic) nervous regulatory mechanisms - indexed by HRV.

  7. Blood pressure in relation to autonomic (sympathetic) nervous system regulation [ Time Frame: within the first 4 days of postnatal life ]
    Study of the relation between physiological parameters - blood pressure (systolic, mean, diastolic - in millimeters of mercury) and sympathetic regulatory mechanisms - indexed by EDA.

  8. Blood pressure in relation to autonomic (parasympathetic) nervous system regulation [ Time Frame: within the first 4 days of postnatal life ]
    Study of the relation between physiological parameters - blood pressure (systolic, mean, diastolic - in millimeters of mercury) and parasympathetic regulatory mechanisms - indexed by HRV.

  9. Blood oxygen saturation in relation to autonomic (sympathetic) nervous system regulation [ Time Frame: within the first 4 days of postnatal life ]
    Study of the relation between physiological parameters - blood oxygen saturation (in percentage) and sympathetic regulatory mechanisms - indexed by EDA.

  10. Blood oxygen saturation in relation to autonomic (parasympathetic) nervous system regulation [ Time Frame: within the first 4 days of postnatal life ]
    Study of the relation between physiological parameters - blood oxygen saturation (in percentage) and parasympathetic regulatory mechanisms - indexed by HRV.

  11. Selected laboratory parameters in relation to autonomic (sympathetic) nervous system regulation [ Time Frame: immediately after birth + on 3rd - 4th postnatal day ]
    Study of the effect of selected laboratory parameters [glycaemia (millimoles per liter), lactate (millimoles per liter), bilirubin (micromoles per liter)] on the sympathetic regulatory mechanisms - indexed by EDA.

  12. Selected laboratory parameters in relation to autonomic (parasympathetic) nervous system regulation [ Time Frame: immediately after birth + on 3rd - 4th postnatal day ]
    Study of the effect of selected laboratory parameters [glycaemia (millimoles per liter), lactate (millimoles per liter), bilirubin (micromoles per liter)] on the parasympathetic regulatory mechanisms - indexed by HRV.

  13. Acid - base parameters in relation to autonomic (sympathetic) nervous system regulation [ Time Frame: immediately after birth + on 3rd - 4th postnatal day ]
    Study of the effect of acid - base parameters [pH, pCO2 (kilopascals), base excess (millimoles per liler)] acquired immediately after birth on the sympathetic regulatory mechanisms - indexed by EDA.

  14. Acid - base parameters in relation to autonomic (parasympathetic) nervous system regulation [ Time Frame: immediately after birth + on 3rd - 4th postnatal day ]
    Study of the effect of acid - base parameters [pH, pCO2 (kilopascals), base excess (millimoles per liler)] acquired immediately after birth on the parasympathetic regulatory mechanisms - indexed by HRV.

  15. Role of psychosocial factors in autonomic (sympathetic) nervous system regulation [ Time Frame: immediately after birth + within the first 4 days of postnatal life ]
    Study of the effect of psychosocial factors (bonding, breastfeeding) on the sympathetic regulatory mechanisms - indexed by EDA.

  16. Role of psychosocial factors in autonomic (parasympathetic) nervous system regulation [ Time Frame: immediately after birth + within the first 4 days of postnatal life ]
    Study of the effect of psychosocial factors (bonding, breastfeeding) on the parasympathetic regulatory mechanisms - indexed by HRV.

  17. Role of umbilical cord clamping in autonomic (sympathetic) nervous system regulation [ Time Frame: at the time of delivery ]
    Study of the effect of immediate vs. delayed cord clamping on sympathetic regulatory mechanisms - indexed by EDA.

  18. Role of umbilical cord clamping in autonomic (parasympathetic) nervous system regulation [ Time Frame: at the time of delivery ]
    Study of the effect of immediate vs. delayed cord clamping on parasympathetic regulatory mechanisms - indexed by HRV.



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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy term newborns with physiological postnatal adaptation born in University Hospital in Martin (Slovakia).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830424


Contacts
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Contact: Mirko Zibolen, Prof, MD +421 434203733 zibolen@jfmed.uniba.sk
Contact: Marek Kozár, MD,PhD +421 434203641 1marekkozar1@gmail.com

Locations
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Slovakia
Jessenius Medical Faculty, Comenius University Not yet recruiting
Martin, Slovakia, 03601
Contact: Mirko Zibolen, Prof, MD    +421 434203733    zibolen@jfmed.uniba.sk   
Sponsors and Collaborators
Comenius University
Investigators
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Study Director: Mirko Zibolen, Prof, MD Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin

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Responsible Party: Comenius University
ClinicalTrials.gov Identifier: NCT03830424     History of Changes
Other Study ID Numbers: EK69/2018
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs