NCT07568418

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
32mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Aug 2025Dec 2028

Study Start

First participant enrolled

August 8, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

April 21, 2026

Last Update Submit

April 30, 2026

Conditions

Mechanical VentilationPainSkin to Skin CareKangaroo Mother Care

Keywords

Skin Conductance MeasurementPainNewborn

Outcome Measures

Primary Outcomes (1)

  • Changes in skin conductance

    Changes in skin conductance measured in micro Siemens

    From the time on one ventilator setting to another, on average about two weeks

Interventions

Skin Conductance MeasurementDEVICE

Objectifying stress by measuring changes in skin conductance using electrodes placed on the infants' feet.

Eligibility Criteria

Age22 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Need for mechanical ventilation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Children's Hospital

Uppsala, Uppland, 75185, Sweden

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Johanna T Walan, Student Researcher

CONTACT

+46704184255johanna.walan@uu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 5, 2026

Study Start

August 8, 2025

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)