Ventilation Distribution During Spontaneous Breathing in Healthy Newborn Infants

NCT ID: NCT03455400

Last Updated: 2020-04-03

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-05

Study Completion Date

2018-08-31

Brief Summary

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Electrical impedance tomography (EIT) is an evolving monitoring tool for respiratory support in neonatal and pediatric intensive care. In this observational study basic EIT parameters will be measured on 20 healthy newborn infants during spontaneous breathing and assess the effect of position changes in ventilation distribution.

Detailed Description

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NEO SensorBelts will be used to observe ventilation distribution in healthy newborn infants during quiet spontaneous breathing. Child's position will be changed 5 times every 10 minutes in a random order. Positions observed will be: left lateral, right lateral, supine, prone face to left, prone face to right and supine with the bed tilted 30 degrees. Total duration for the recording will be 1 hour.

Conditions

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Spontaneous Breathing Full-Term Neonate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Swisstom BB2 EIT device

Swisstom BB2 EIT device with NEO SensorBelts will be used to measure ventilation distribution during spontaneous breathing and position changes in healthy newborn infants.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent from a parent or legal guardian
* Gestational age 37+0 - 42+0 weeks
* Uneventful follow-up in maternity ward

Exclusion Criteria

* Respiratory distress
* Admission to NICU
* Thorax skin lesions
* Prior participation in this study
Minimum Eligible Age

12 Hours

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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EETTMK:104/2017

Identifier Type: -

Identifier Source: org_study_id

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