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Completed

NCT Number: NCT03455400

Ventilation Distribution 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.

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Key information

Conditions

Spontaneous Breathing Full-Term Neonate

Age range

12 hour–5 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Oulu University Hospital

Oulu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swisstom BB2 EIT device

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.

Primary outcomes

  1. 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.

  2. Right-to-left ventilation distribution

    Time frame: 1 hour

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

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2018
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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