Continuous Regional Analysis Device for Neonate Lung

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

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-03-03

Brief Summary

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The purpose of the study is to assess whether Electrical Impedance Tomography (EIT) has the potential to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, recruitment manoeuvres, etc.) and for early recognition of complications like pneumothorax and endotracheal tube misplacement. The study design is purely observational.

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Detailed Description

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EIT data will be recorded during 72 hours of routine clinical treatment. To prevent any decisions based on EIT information, the clinicians will be blinded to the EIT findings during the study period. Data on clinical interventions and clinical findings will be recorded using a specially adapted graphical user interface on the EIT device in combination with a paper-based case report form (CRF). EIT data analysis will be performed off-line.

Conditions

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Infant Respiratory Distress Syndrome Acute Bronchiolitis Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Written, informed consent of both parents or legal representative
* Admission in the NICU or PICU
* Patients with or at high risk of developing respiratory failure needing respiratory support.

o i.e. (oxygen need (FiO2\>25%) AND noninvasive or invasive respiratory support) AND/OR repeated apnea with desaturations
* Age from birth to 7 years o Initial focus will be on neonates up to 6 kg and 12 months age. Infants of higher weight up to 7 years age will be included as EIT belts for this age group become available.

Exclusion Criteria

* Post menstrual age less than 25 weeks
* Body weight \< 600 g
* Electrically active implants
* Thorax skin lesions
* Prior participation for the same diagnosis of lung disease

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No