NCT03455400

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

February 27, 2018

Last Update Submit

April 2, 2020

Conditions

Spontaneous BreathingFull-Term Neonate

Outcome Measures

Primary Outcomes (2)

  • Anteroposterior ventilation distribution

    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

    Changes in right-to-left ventilation distribution following position changes will be calculated

    1 hour

Interventions

Swisstom BB2 EIT deviceDEVICE

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

Eligibility Criteria

Age12 Hours - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

20 healthy full-term infants

You may qualify if:

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

You may not qualify if:

  • Respiratory distress
  • Admission to NICU
  • Thorax skin lesions
  • Prior participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 6, 2018

Study Start

March 5, 2018

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)