Repeatability and Feasibility of Infant Spirometry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01057472

Enrollment

Registered

2010-01-27

Start date

2010-01-31

Completion date

2011-12-31

Last updated

2012-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Keywords

Repeatability of measurements

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Weeks to 3 Months

Healthy volunteers

Yes

Inclusion criteria

* Being a Term born and preterm born babies

Exclusion criteria

* Being in an unstable clinical condition

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Feasibility of the measurements in the NICU	1 year

Countries

Norway

Outcome results