Assessment of Autonomic Nervous Regulation During Postnatal Period in Newborns

Comenius University

Status: Unknown

Conditions: Infant, Newborn

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

Study type: Observational

Funder types: Other

Identifiers

NCT03830424

EK69/2018

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 1 hour to 4 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

75 participants in 3 patient groups

Control group

Description:

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

Treatment:

Procedure: Pain stimulus

Sucrose group

Description:

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

Treatment:

Dietary Supplement: Non-pharmacological pain relief

Procedure: Pain stimulus

Mother milk group

Description:

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

Treatment:

Dietary Supplement: Non-pharmacological pain relief

Procedure: Pain stimulus