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Recruiting NCT07568418

Skin Conductance in Ventilated Preterms

No phase Interventional Mechanical Ventilation Pain Skin to Skin Care Kangaroo Mother Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Skin Conductance Measurement.
Who it may be relevant to
Registry conditions: Mechanical Ventilation, Pain, Skin to Skin Care, Kangaroo Mother Care. Basic parameters: from 22 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pain Assessment Using Skin Conductance Measurement During Different Types of Invasive Ventilation in Newborn Infants

Overview

The goal of this observational study is to learn more about the pain and stress experienced by newborn infants receiving mechanical ventilation (breathing through a machine). The main questions it aims to answer are: * Do different ventilator settings (modi) cause different degrees of pain and stress? * Can skin conductance measurement be used to evaluate the pain and stress caused by mechanical ventilation in newborns? * Can skin-to-skin care alleviate the stress caused by mechanical ventilation? Participants will be monitored according to clinical protocol with the addition of electrodes placed on the infant's foot, measuring changes in skin conductance.

Interventions

  • Device Skin Conductance Measurement
    Objectifying stress by measuring changes in skin conductance using electrodes placed on the infants' feet.

Primary outcome measures

  • Changes in skin conductance [Time frame: From the time on one ventilator setting to another, on average about two weeks]

Eligibility criteria

Inclusion criteria

  • Need for mechanical ventilation

Exclusion criteria

  • Other distracting painful conditions
  • Facial malformation or neuromuscular disease, not allowing regular visual pain assessment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Diagnostic

Study locations

Sweden · 1 center
  • Uppsala University Children's Hospital — Uppsala

Identifiers

NCT: NCT07568418 · Dnr 2023-03900-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗