Ventilation Distribution During Spontaneous Breathing in Healthy Newborn Infants

April 2, 2020 updated by: University of Oulu

Ventilation Distribution Observed With Electrical Impedance Tomography (EIT) During Spontaneous Breathing in Healthy Newborn Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20 healthy full-term infants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anteroposterior ventilation distribution
Time Frame: 1 hour
The ventral-to-dorsal center of ventilation will be calculated as described in (Frerichs et al., Acta AnaesthesiolScand. 1998; 42:721-726) as a value between 0 and 100%, higher values indicating a more dorsal distribution of ventilation.
1 hour
Right-to-left ventilation distribution
Time Frame: 1 hour
Changes in right-to-left ventilation distribution following position changes will be calculated
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EETTMK:104/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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