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NCT01057472 Clinical Trial

Repeatability and Feasibility of Infant Spirometry

Prematurity Clinical Trial

Official title:
Repeatability and Feasibility of Infant Spirometry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01057472
Other study ID # REK Vest 2009/1771
Secondary ID
Status Completed
Phase N/A
First received January 26, 2010
Last updated January 24, 2012
Start date January 2010
Est. completion date December 2011

Study information
Verified date January 2012
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

- Being a Term born and preterm born babies

Exclusion Criteria:

- Being in an unstable clinical condition

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Pediatric Department, NICU Bergen

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Before and after a meal No
Secondary Feasibility of the measurements in the NICU 1 year No
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