Ventilation Distribution During Spontaneous Breathing in Healthy Newborn Infants

Completed

• Conditions: Full-Term Neonate; Spontaneous Breathing

• Registration Number: NCT03455400
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-02-27
• Study Start: 2018-03-05
• Study First Posted: 2018-03-06
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Right-to-left ventilation distribution	1 hour	Changes in right-to-left ventilation distribution following position changes will be calculated
Anteroposterior ventilation distribution	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.

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland