Repeatability and Feasibility of Infant Spirometry

Haukeland University Hospital30 enrolled

Overview

This is a study examining repeatability and feasibility of a new method for measurement of lung function in babies. A flexible vest is placed around the torso of the baby, and changes in tidal volume and flow is measured. The study will enable a better understanding of the usefulness of this equipment in a neonatal intensive care unit. The equipment is made by VOLUSENSE Norway AS, and marketed under the name FloRight. The equipment is owned by Volusense Norway AS during the study period.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prematurity

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 3 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Being a Term born and preterm born babies Exclusion Criteria: * Being in an unstable clinical condition

Locations (1)

Pediatric Department, NICU

Bergen, Norway

Outcomes

Primary Outcomes

Repeatability of measurements performed by two different nurses before and after a meal in term babies (10), preterm babies before discharge (10) and preterm babies weighing approximately 1500 grams

Time frame: Before and after a meal

Secondary Outcomes

Feasibility of the measurements in the NICU

Time frame: 1 year

Data from ClinicalTrials.gov

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