Ventilation Distribution During Spontaneous Breathing in Healthy Newborn Infants

Spontaneous Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455400
• Other study ID #: EETTMK:104/2017
• Status: Completed
• Start date: March 5, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: April 2020
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Days

Eligibility

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

Related Conditions & MeSH terms

• Full-Term Neonate
• Respiratory Aspiration
• Spontaneous Breathing

Intervention

Device:
• Swisstom BB2 EIT 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.

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Right-to-left ventilation distribution	Changes in right-to-left ventilation distribution following position changes will be calculated	1 hour