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CompletedNCT01057472Updated Jan 25, 2012

Repeatability and Feasibility of Infant Spirometry

An observational study in Prematurity, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 4 Weeks to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-25.

Sponsored by Haukeland University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
4 Weeks to 3 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Prematurity

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Keywords

  • Repeatability of measurements
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 30 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Weeks to 3 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Term born and preterm born babies

Inclusion criteria

  • Being a Term born and preterm born babies

Exclusion criteria

Exclusion Criteria:

  • Being in an unstable clinical condition
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)

Groups and cohorts

  • Term born babies

    Term born babies

  • Preterm babies ready for discharge

    Preterm babies ready for discharge

  • Preterm stable babies 1500 grams

    Preterm stable babies 1500 grams

06

What researchers measure

Primary outcomes

  1. 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

  1. Feasibility of the measurements in the NICU

    Time frame: 1 year

07

Study locations

1 site
  • Pediatric Department, NICU
    Bergen, 5021, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01057472
Lead sponsor
Haukeland University Hospital
Responsible party
Sponsor
First posted
Jan 27, 2010
Start date
Jan 2010
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jan 25, 2012

Study contacts

Thomas Halvorsen, MD, PhD
principal investigator · Haukeland University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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