PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring

NCT ID: NCT06171867

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-24

Study Completion Date

2024-02-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Neonatal Respiratory Distress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The device feasibility will be assessed in clinical environment with feedback from both the patient parents and nurses in NICU/PICU.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Feasibility of the PNEUMACRIT belt

Neonates will be monitored with a PNEUMACRIT electrode belt for 6 to 24 hours. After the study period, patient parents and nurses will give feedback.

Group Type EXPERIMENTAL

PNEUMACRIT

Intervention Type DEVICE

Monitoring of breathing

Interventions

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PNEUMACRIT

Monitoring of breathing

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

12 Hours

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Middlesex University

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Merja Kallio

MD, PhD, Principal investigator, Associate professor of pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

Related Links

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Other Identifiers

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EETTMK: 73/2021

Identifier Type: -

Identifier Source: org_study_id

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