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Repeatability and Feasibility of Infant Spirometry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01057472
First received: January 26, 2010
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition
Prematurity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Repeatability and Feasibility of Infant Spirometry

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility of the measurements in the NICU [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Term born and preterm born babies

Criteria

Inclusion Criteria:

  • Being a Term born and preterm born babies

Exclusion Criteria:

  • Being in an unstable clinical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057472

Locations
Norway
Pediatric Department, NICU
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Thomas Halvorsen, MD, PhD Haukeland University Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01057472     History of Changes
Other Study ID Numbers: REK Vest 2009/1771
Study First Received: January 26, 2010
Last Updated: January 24, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
Repeatability of measurements

ClinicalTrials.gov processed this record on May 22, 2013