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Clinical Trials/NCT06171867
NCT06171867
Completed
Not Applicable

Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability

University of Oulu1 site in 1 country20 target enrollmentNovember 24, 2023
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ConditionsNeonatal Respiratory Distress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Respiratory Distress
Sponsor
University of Oulu
Enrollment
20
Locations
1
Primary Endpoint
Proportion (%) of recording time with high quality EIT-signal
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.

Detailed Description

Electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. This feasibility study will assess the usability of a new PNEUMACRIT electrode belt in clinical environment.

Registry
clinicaltrials.gov
Start Date
November 24, 2023
End Date
February 25, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Merja Kallio

MD, PhD, Principal investigator, Associate professor of pediatrics

University of Oulu

Eligibility Criteria

Inclusion Criteria

  • •Inpatient at Oulu University Hospital PICU or NICU
  • •Gestational age at birth over 32 weeks
  • •Weight 2000-5000g
  • •Postnatal age \> 12 hours
  • •Written informed consent from the parents of legal representative
  • •Non-invasive monitoring of oxygen saturation and ECG

Exclusion Criteria

  • •Postmenstrual age \< 32 weeks
  • •Weight at time of the study \< 2000g or \> 5000g
  • •Chest skin lesion preventing safe use of the electrode belt
  • •Recent chest surgery within the past 7 days (e.g. thoracotomy)

Outcomes

Primary Outcomes

Proportion (%) of recording time with high quality EIT-signal

Time Frame: 6-24 hours

Proportion of time that the collected EIT signal is accurate enough for reliable image reconstruction and observations of changes in lung aeration

Secondary Outcomes

  • Staff and parent questionnaires(48 hours)

Study Sites (1)

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