Trials / Unknown
UnknownNCT03830424
Assessment of Autonomic Nervous Regulation During Postnatal Period in Newborns
Assessment of Autonomic Nervous System Regulatory Mechanisms During Postnatal Period in Newborns
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (actual)
- Sponsor
- Comenius University · Academic / Other
- Sex
- All
- Age
- 1 Hour – 4 Days
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-02-15
- Primary completion
- 2022-10-01
- Completion
- 2022-12-31
- First posted
- 2019-02-05
- Last updated
- 2022-01-04
Locations
1 site across 1 country: Slovakia
Source: ClinicalTrials.gov record NCT03830424. Inclusion in this directory is not an endorsement.