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Ventilation Distribution During Spontaneous Breathing in Healthy Newborn Infants

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03455400
Enrollment
20
Registered
2018-03-06
Start date
2018-03-05
Completion date
2018-08-31
Last updated
2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full-Term Neonate, Spontaneous Breathing

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.

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.

Interventions

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

Sponsors

University of Oulu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Hours to 5 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Right-to-left ventilation distribution1 hourChanges in right-to-left ventilation distribution following position changes will be calculated
Anteroposterior ventilation distribution1 hourThe 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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026